Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2009-5437

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: Prosar 1-20839721

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.

25-NOV-09

5. Lieu de l'incident.

Pays: UNITED STATES

État: CONNECTICUT

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

24-NOV-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. 2596-140

Nom du produit: UltraGuard Plus Flea/Tick Spray for Cats 8 fl oz

• Matière active
  • (S)-METHOPRENE
    • Garantie/concentration .07 %
  • TETRACHLORVINPHOS
    • Garantie/concentration 1.08 %

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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 3 cats on 11/24/2009. Tylenol may have been given to one cat (Tylenol is toxic to cats).

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

Domestic Shorthair

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

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

0.5

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

4

lbs

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

>8 hrs <= 24 hrs / >8 h <= 24 h

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

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• Système gastro-intestinal
  • Symptôme - Anorexie

• General
  • Symptôme - Lethargie

• Systèmes nerveux et musculaire
  • Symptôme - Ataxie

• 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

1-20839721: A reporter (cat owner) called on 11/25/2009 to report the exposure of his 3 cats to a flea and tick spray containing the active ingredients Tetrachlorvinphos and Methoprene. According to the reporter, the product was applied to the cats on 11/24/2009. At an unknown time following product application, Cat #1 (1st Subform III) developed anorexia, lethargy, and ataxia. Cats #2 (2nd Subform III) and #3 (3rd Subform III) developed anorexia and lethargy. The reporter bathed all 3 cats on 11/23/2009, and stated he gave Cat #1 Tylenol. The reporter then said that he did not give Cat #1 Tylenol. All 3 cats were still having signs at the time of the report. The reporter was advised that the product is not expected to result in adverse effects with routine use. A recommendation was made to decontaminate the cats with a non-insecticidal shampoo and have them evaluated by a veterinarian if signs persist. The reporter was also advised that Tylenol is toxic to cats, and any cat that had been given Tylenol needs to be seen immediately by a veterinarian. The reporter called back on 11/27/2009 to state that Cat #1 died on 11/26/2009. The other 2 cats developed salivation and trouble walking. They were taken to a veterinarian and the reporter wanted to know what treatment should be provided. The reporter was advised that there is a blood test to confirm whether the signs are consistent with product toxicity. He was again advised that the product is not expected to cause adverse effects with labeled use. Over-application of the product or the use of product on an ill animal may result in signs of toxicity. The reporter was also advised to have the veterinarian call with any questions about case management. On follow up in 11/30/2009, the reporter stated that Cats #2 and #3 were doing well. He was unsure what treatments they received and what the diagnosis was. On 12/04/2009, the reporter called to say that Cat #2 had passed away at an unknown time. Cat #3 was fine at the time of the call back. 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

Domestic Shorthair

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

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

2

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

10

lbs

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

>8 hrs <= 24 hrs / >8 h <= 24 h

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

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• Système gastro-intestinal
  • Symptôme - Anorexie

• General
  • Symptôme - Lethargie

• Système gastro-intestinal
  • Symptôme - Salivation excessive

• Systèmes nerveux et musculaire
  • Symptôme - Difficulté de marcher

• 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.

Oui

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

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

1-20839721: A reporter (cat owner) called on 11/25/2009 to report the exposure of his 3 cats to a flea and tick spray containing the active ingredients Tetrachlorvinphos and Methoprene. According to the reporter, the product was applied to the cats on 11/24/2009. At an unknown time following product application, Cat #1 (1st Subform III) developed anorexia, lethargy, and ataxia. Cats #2 (2nd Subform III) and #3 (3rd Subform III) developed anorexia and lethargy. The reporter bathed all 3 cats on 11/23/2009, and stated he gave Cat #1 Tylenol. The reporter then said that he did not give Cat #1 Tylenol. All 3 cats were still having signs at the time of the report. The reporter was advised that the product is not expected to result in adverse effects with routine use. A recommendation was made to decontaminate the cats with a non-insecticidal shampoo and have them evaluated by a veterinarian if signs persist. The reporter was also advised that Tylenol is toxic to cats, and any cat that had been given Tylenol needs to be seen immediately by a veterinarian. The reporter called back on 11/27/2009 to state that Cat #1 died on 11/26/2009. The other 2 cats developed salivation and trouble walking. They were taken to a veterinarian and the reporter wanted to know what treatment should be provided. The reporter was advised that there is a blood test to confirm whether the signs are consistent with product toxicity. He was again advised that the product is not expected to cause adverse effects with labeled use. Over-application of the product or the use of product on an ill animal may result in signs of toxicity. The reporter was also advised to have the veterinarian call with any questions about case management. On follow up in 11/30/2009, the reporter stated that Cats #2 and #3 were doing well. He was unsure what treatments they received and what the diagnosis was. On 12/04/2009, the reporter called to say that Cat #2 had passed away at an unknown time. Cat #3 was fine at the time of the call back. 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

Domestic Shorthair

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

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

2

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

8

lbs

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

>8 hrs <= 24 hrs / >8 h <= 24 h

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

Unknown / Inconnu

11. Énumérer tous les symptômes

Système

• Système gastro-intestinal
  • Symptôme - Anorexie

• General
  • Symptôme - Lethargie

• Système gastro-intestinal
  • Symptôme - Salivation excessive

• Systèmes nerveux et musculaire
  • Symptôme - Difficulté de marcher

12. Quelle a été la durée des symptômes?

Unknown / Inconnu

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

Oui

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

Fully Recovered / Complètement rétabli

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

1-20839721: A reporter (cat owner) called on 11/25/2009 to report the exposure of his 3 cats to a flea and tick spray containing the active ingredients Tetrachlorvinphos and Methoprene. According to the reporter, the product was applied to the cats on 11/24/2009. At an unknown time following product application, Cat #1 (1st Subform III) developed anorexia, lethargy, and ataxia. Cats #2 (2nd Subform III) and #3 (3rd Subform III) developed anorexia and lethargy. The reporter bathed all 3 cats on 11/23/2009, and stated he gave Cat #1 Tylenol. The reporter then said that he did not give Cat #1 Tylenol. All 3 cats were still having signs at the time of the report. The reporter was advised that the product is not expected to result in adverse effects with routine use. A recommendation was made to decontaminate the cats with a non-insecticidal shampoo and have them evaluated by a veterinarian if signs persist. The reporter was also advised that Tylenol is toxic to cats, and any cat that had been given Tylenol needs to be seen immediately by a veterinarian. The reporter called back on 11/27/2009 to state that Cat #1 died on 11/26/2009. The other 2 cats developed salivation and trouble walking. They were taken to a veterinarian and the reporter wanted to know what treatment should be provided. The reporter was advised that there is a blood test to confirm whether the signs are consistent with product toxicity. He was again advised that the product is not expected to cause adverse effects with labeled use. Over-application of the product or the use of product on an ill animal may result in signs of toxicity. The reporter was also advised to have the veterinarian call with any questions about case management. On follow up in 11/30/2009, the reporter stated that Cats #2 and #3 were doing well. He was unsure what treatments they received and what the diagnosis was. On 12/04/2009, the reporter called to say that Cat #2 had passed away at an unknown time. Cat #3 was fine at the time of the call back. 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)

Modérée

19. Donner des renseignements additionnels ici