Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2009-3992

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: Prosar 1-19551601

Nom du titulaire (nom légal complet, aucune abbréviation): The Hartz Mountain Corporation

Adresse: 400 Plaza Drive

Ville: Secaucus

État: New Jersey

Pays: USA

Code postal /Zip: 07094-3688

3.Choisir le (les) sous-formulaire(s) correspondant à l'incident.

Incident chez un animal domestique

4. Date à laquelle le titulaire d'homologation a été informé pour la première fois de l'incident.

17-AUG-09

5. Lieu de l'incident.

Pays: UNITED STATES

État: MICHIGAN

6. Date de la première observation de l'incident.

14-AUG-09

Description du produit

7. a) Donner le nom de la matière active et, si disponibles, le numéro d'homologation et le nom du produit (incluant tous les mélanges). Si le produit n'est pas homologué, donner le numéro de la demande d'homologation.

Matière(s) active(s)

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ARLA No d'homologation       ARLA No de la demande d'homologation       EPA No d'homologation. 2596-147

Nom du produit: UltraGuard One Spot Flea Egg/Larvae Treatment for Cats/Kittens

• Matière active
  • (S)-METHOPRENE
    • Garantie/concentration 2.9 %

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7. b) Type de formulation.

Liquide

Renseignments sur l'application

8. Est-ce que le produit a été appliqué?

Oui

9. Dose d'application.

Inconnu

10. Site d'application (choisir tout ce qui s'applique).

Site: Animal / Usage sur un animal domestique

11. Donner tout renseignement additionnel concernant l'application (comment le produit a été appliqué, la quantité utilisée, la superficie de la zone traitée, etc.)

The product was applied to 4 cats on 08/11/2009.

À être déterminé par le titulaire

12. Selon vous, le produit a-t-il été utilisé en conformité avec le mode d'emploi de L'étiquette?

Inconnu

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Cat / Chat

3. Race

Himalayan

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

6. Âge (fournir un ordre de grandeur si nécessaire)

5

7. Poids (fournir un ordre de grandeur si nécessaire)

Inconnu

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

>24 hrs <=3 days / >24 h <=3 jours

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Vocalisation

• Système respiratoire
  • Symptôme - Respiration profonde
  • Specify - "Breathing deep and not as often as normal"

• Systèmes nerveux et musculaire
  • Symptôme - Spasme musculaire

• General
  • Symptôme - Mort

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Non

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Non

14. b) Combien de temps l'animal était-il hospitalisé?

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Treatment / Traitement

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

1-19551601: A reporter (cat owner) called on 08/17/2009 to report the exposure of her 4 cats to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, the product was applied to the cats on 08/11/2009. On 08/14/2009, Cat #1 (1st Subform III) was vocalizing and breathing deeply and less often than normal. Cat #1 began to spasm on 08/15/2009 and died on 08/16/2009. The cat was not evaluated by a veterinarian. On 08/17/2009, Cat #2 (2nd Subform III) began acting lethargic. The other 2 cats were asymptomatic at the time of the initial report. The reporter was advised that the active ingredient has little to no mammalian toxicity, and adverse reactions would not be expected. A recommendation was made to bathe the Cat #2 with a hand dish soap. The reporter was also advised that if the signs persist, Cat #2 should be evaluated by a veterinarian to determine the cause of the signs. The reporter called again on 08/17/2009 to report that Cat #2 had been bathed and died a short time later. The reporter was advised to consider necropsy to determine the cause of death. The reporter called on 08/21/2009 to report that Cat #3 (3rd Subform III) had died on 08/20/2009. It is unknown what signs Cat #3 had prior to death. All 4 cats had been bathed after the initial report. At the time of the most recent report, Cat #4 was lethargic and not eating. None of the cats had been evaluated by a veterinarian since the start of their signs. The reporter was again advised that the signs reported are not expected with product use. The reporter was encouraged to have Cat #4 evaluated by a veterinarian. The reporter called back on 08/31/2009 to report that Cat #4 had died on 08/30/2009. Cat #4 had not been evaluated by a veterinarian. No further information was obtained.

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Cat / Chat

3. Race

Himalayan

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

6. Âge (fournir un ordre de grandeur si nécessaire)

4

7. Poids (fournir un ordre de grandeur si nécessaire)

Inconnu

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

>3 days <=1 wk / >3 jours <=1 sem

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Lethargie
  • Symptôme - Mort

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Non

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Non

14. b) Combien de temps l'animal était-il hospitalisé?

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Treatment / Traitement

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

1-19551601: A reporter (cat owner) called on 08/17/2009 to report the exposure of her 4 cats to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, the product was applied to the cats on 08/11/2009. On 08/14/2009, Cat #1 (1st Subform III) was vocalizing and breathing deeply and less often than normal. Cat #1 began to spasm on 08/15/2009 and died on 08/16/2009. The cat was not evaluated by a veterinarian. On 08/17/2009, Cat #2 (2nd Subform III) began acting lethargic. The other 2 cats were asymptomatic at the time of the initial report. The reporter was advised that the active ingredient has little to no mammalian toxicity, and adverse reactions would not be expected. A recommendation was made to bathe the Cat #2 with a hand dish soap. The reporter was also advised that if the signs persist, Cat #2 should be evaluated by a veterinarian to determine the cause of the signs. The reporter called again on 08/17/2009 to report that Cat #2 had been bathed and died a short time later. The reporter was advised to consider necropsy to determine the cause of death. The reporter called on 08/21/2009 to report that Cat #3 (3rd Subform III) had died on 08/20/2009. It is unknown what signs Cat #3 had prior to death. All 4 cats had been bathed after the initial report. At the time of the most recent report, Cat #4 was lethargic and not eating. None of the cats had been evaluated by a veterinarian since the start of their signs. The reporter was again advised that the signs reported are not expected with product use. The reporter was encouraged to have Cat #4 evaluated by a veterinarian. The reporter called back on 08/31/2009 to report that Cat #4 had died on 08/30/2009. Cat #4 had not been evaluated by a veterinarian. No further information was obtained.

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Cat / Chat

3. Race

Unknown breed

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

6. Âge (fournir un ordre de grandeur si nécessaire)

6

7. Poids (fournir un ordre de grandeur si nécessaire)

Inconnu

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

>3 days <=1 wk / >3 jours <=1 sem

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Mort

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Non

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Non

14. b) Combien de temps l'animal était-il hospitalisé?

15. Issue de l'incident

Mort

16. De quelle manière l'animal a-t-il été exposé?

Treatment / Traitement

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

1-19551601: A reporter (cat owner) called on 08/17/2009 to report the exposure of her 4 cats to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, the product was applied to the cats on 08/11/2009. On 08/14/2009, Cat #1 (1st Subform III) was vocalizing and breathing deeply and less often than normal. Cat #1 began to spasm on 08/15/2009 and died on 08/16/2009. The cat was not evaluated by a veterinarian. On 08/17/2009, Cat #2 (2nd Subform III) began acting lethargic. The other 2 cats were asymptomatic at the time of the initial report. The reporter was advised that the active ingredient has little to no mammalian toxicity, and adverse reactions would not be expected. A recommendation was made to bathe the Cat #2 with a hand dish soap. The reporter was also advised that if the signs persist, Cat #2 should be evaluated by a veterinarian to determine the cause of the signs. The reporter called again on 08/17/2009 to report that Cat #2 had been bathed and died a short time later. The reporter was advised to consider necropsy to determine the cause of death. The reporter called on 08/21/2009 to report that Cat #3 (3rd Subform III) had died on 08/20/2009. It is unknown what signs Cat #3 had prior to death. All 4 cats had been bathed after the initial report. At the time of the most recent report, Cat #4 was lethargic and not eating. None of the cats had been evaluated by a veterinarian since the start of their signs. The reporter was again advised that the signs reported are not expected with product use. The reporter was encouraged to have Cat #4 evaluated by a veterinarian. The reporter called back on 08/31/2009 to report that Cat #4 had died on 08/30/2009. Cat #4 had not been evaluated by a veterinarian. No further information was obtained.

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Cat / Chat

3. Race

Himalayan

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

6. Âge (fournir un ordre de grandeur si nécessaire)

8

7. Poids (fournir un ordre de grandeur si nécessaire)

Inconnu

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

Unknown / Inconnu

10. Temps écoulé entre l'exposition et l'apparition des symptômes

>1 wk <=1 mo / > 1 sem < = 1 mois

11. Énumérer tous les symptômes

Système

• General
  • Symptôme - Lethargie

• Système gastro-intestinal
  • Symptôme - Anorexie

• General
  • Symptôme - Mort

12. Quelle a été la durée des symptômes?

Persisted until death

13. Des soins médicaux ont-ils été prodigués? Donner les détails à la question 17.

Inconnu

14. a) Est-ce que l'animal a-t-il été hospitalisé?

Inconnu

14. b) Combien de temps l'animal était-il hospitalisé?

15. Issue de l'incident

Unknown/Inconnu

16. De quelle manière l'animal a-t-il été exposé?

Treatment / Traitement

17. Donnez tout détail additionnel au sujet de l'incident

(p.ex. description des symptômes tels que la fréquence et la gravité

1-19551601: A reporter (cat owner) called on 08/17/2009 to report the exposure of her 4 cats to a flea egg and larvae product containing the active ingredient Methoprene. According to the reporter, the product was applied to the cats on 08/11/2009. On 08/14/2009, Cat #1 (1st Subform III) was vocalizing and breathing deeply and less often than normal. Cat #1 began to spasm on 08/15/2009 and died on 08/16/2009. The cat was not evaluated by a veterinarian. On 08/17/2009, Cat #2 (2nd Subform III) began acting lethargic. The other 2 cats were asymptomatic at the time of the initial report. The reporter was advised that the active ingredient has little to no mammalian toxicity, and adverse reactions would not be expected. A recommendation was made to bathe the Cat #2 with a hand dish soap. The reporter was also advised that if the signs persist, Cat #2 should be evaluated by a veterinarian to determine the cause of the signs. The reporter called again on 08/17/2009 to report that Cat #2 had been bathed and died a short time later. The reporter was advised to consider necropsy to determine the cause of death. The reporter called on 08/21/2009 to report that Cat #3 (3rd Subform III) had died on 08/20/2009. It is unknown what signs Cat #3 had prior to death. All 4 cats had been bathed after the initial report. At the time of the most recent report, Cat #4 was lethargic and not eating. None of the cats had been evaluated by a veterinarian since the start of their signs. The reporter was again advised that the signs reported are not expected with product use. The reporter was encouraged to have Cat #4 evaluated by a veterinarian. The reporter called back on 08/31/2009 to report that Cat #4 had died on 08/30/2009. Cat #4 had not been evaluated by a veterinarian. No further information was obtained.

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À être déterminé par le titulaire

Classification selon la gravité (s'il y a plus d'une catégorie possible, veuillez choisir la plus grave)

Mort

19. Donner des renseignements additionnels ici