Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2010-3786

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: PROSAR Case #1-23526970

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.

21-JUL-10

5. Lieu de l'incident.

Pays: UNITED STATES

État: TEXAS

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

19-JUN-10

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. 2596-150

Nom du produit: UltraGuard Plus Flea Tick Drops Plus for Dogs Puppies 4-15 lbs

• Matière active
  • (S)-METHOPRENE
    • Garantie/concentration 2.3 %
  • D-PHENOTHRIN
    • Garantie/concentration 85.7 %

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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.)

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

Dog / Chien

3. Race

mix

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

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

3

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

9

lbs

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

• Peau
  • Symptôme -

• Système gastro-intestinal
  • Symptôme - Vomit
  • Symptôme - Diarrhée

• General
  • Symptôme - Lethargie

• Foie
  • Symptôme - Grossissement du foie

• Système reproducteur
  • Symptôme - Autre
  • Specify - uterine enlargement

• Foie
  • Symptôme - Taux élevé d'enzymes du foie

• 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.

Oui

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

Oui

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

4

Day(s) / Jour(s)

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

1-23526970- The reporter, a pet owner, calls to report exposure of her animals to an insecticide containing the active ingredients phenothrin and methoprene. The pet owner reports applying the topical flea and tick drop to her two dogs one month prior to the initial contact with the registrant. The first dog, a one year male nine pound mixed breed (Subform III, #2), was reported to have developed generalized pruritis shortly after application (unspecified time frame). The sign spontaneously resolve within by the next day, but later that same day the animal developed localized dermal hives. The sign persisted for three days at which point the owner contacted their veterinarian by phone and were told to use oral diphenhydramine on the dog. The hives resolve (unspecified time frame) but the animal developed a diminished appetite and lethargy nine to ten days after application which spontaneously resolved within one week. This animal has remained asymptomatic beyond that point. The second dog, a three year female nine pound mixed breed (Subform III, #1), developed the same pruritic sign of the same duration and was also placed on diphenhydramine though she never developed the dermal hives. Nine to ten days after application the animal demonstrated vomiting and anorexia of unspecified severity and duration. Eighteen to nineteen days after application the animal developed lethargy, anorexia, vomiting and diarrhea at which point the animal was brought to the veterinarian. The veterinarian, following examination and abdominal ultrasound, reported dehydration, hepatic and uterine enlargement. The animal was not sterilized, so a uterine infection (pyometra) was a major rule out, according to the owner. The owner reports blood tests (unspecified) at this point indicated the animals liver enzymes (unspecified) were elevated. The animal was placed on intravenous fluids and hospitalized for four days. Following release to the owner the animal failed to thrive at home (signs not explained) and was brought to the emergency veterinarian within 24 hours of release from her regular veterinarian. She was reported to have died within 10 minutes of presenting at the emergency veterinarian. The pet owner was told the signs observed and outcome seen would not be expected following use of the product per the label instructions. Dermal and neurologic signs can bee seen immediately following overdosage scenarios with the active ingredient. The signs, and time line described are inconsistent with the toxicity profile of the active ingredient following overdosage and overdosage was not described. The animal was likely suffering from an unrelated illness that might be revealed with necropsy. No further information is available.

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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

Dog / Chien

3. Race

mix

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

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

1

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

9

lbs

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

Unknown / Inconnu

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

>30 min <=2 hrs / >30 min <=2 h

11. Énumérer tous les symptômes

Système

• Peau
  • Symptôme -
  • Symptôme - Urticaire

• General
  • Symptôme - Lethargie

• Système gastro-intestinal
  • Symptôme - Anorexie

12. Quelle a été la durée des symptômes?

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

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?

Non

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

1-23526970- The reporter, a pet owner, calls to report exposure of her animals to an insecticide containing the active ingredients phenothrin and methoprene. The pet owner reports applying the topical flea and tick drop to her two dogs one month prior to the initial contact with the registrant. The first dog, a one year male nine pound mixed breed (Subform III, #2), was reported to have developed generalized pruritis shortly after application (unspecified time frame). The sign spontaneously resolve within by the next day, but later that same day the animal developed localized dermal hives. The sign persisted for three days at which point the owner contacted their veterinarian by phone and were told to use oral diphenhydramine on the dog. The hives resolve (unspecified time frame) but the animal developed a diminished appetite and lethargy nine to ten days after application which spontaneously resolved within one week. This animal has remained asymptomatic beyond that point. The second dog, a three year female nine pound mixed breed (Subform III, #1), developed the same pruritic sign of the same duration and was also placed on diphenhydramine though she never developed the dermal hives. Nine to ten days after application the animal demonstrated vomiting and anorexia of unspecified severity and duration. Eighteen to nineteen days after application the animal developed lethargy, anorexia, vomiting and diarrhea at which point the animal was brought to the veterinarian. The veterinarian, following examination and abdominal ultrasound, reported dehydration, hepatic and uterine enlargement. The animal was not sterilized, so a uterine infection (pyometra) was a major rule out, according to the owner. The owner reports blood tests (unspecified) at this point indicated the animals liver enzymes (unspecified) were elevated. The animal was placed on intravenous fluids and hospitalized for four days. Following release to the owner the animal failed to thrive at home (signs not explained) and was brought to the emergency veterinarian within 24 hours of release from her regular veterinarian. She was reported to have died within 10 minutes of presenting at the emergency veterinarian. The pet owner was told the signs observed and outcome seen would not be expected following use of the product per the label instructions. Dermal and neurologic signs can bee seen immediately following overdosage scenarios with the active ingredient. The signs, and time line described are inconsistent with the toxicity profile of the active ingredient following overdosage and overdosage was not described. The animal was likely suffering from an unrelated illness that might be revealed with necropsy. No further information is available.

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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