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Sécurité des produits de consommation

Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2007-7751

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: PROSAR Case 1-15119480

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.

18-JUL-07

5. Lieu de l'incident.

Pays: CANADA

État: BRITISH COLUMBIA

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

17-JUL-07

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)

ARLA No d'homologation 26490      ARLA No de la demande d'homologation       EPA No d'homologation.

Nom du produit: Control Pet Care System One Spot for Dogs + Puppies Over 14 kg

  • Matière active
    • (S)-METHOPRENE
    • PERMETHRIN

7. b) Type de formulation.

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

Mixed Breed

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)

90

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

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

11. Énumérer tous les symptômes

Système

  • Peau
    • Symptôme - Prurit
  • Système gastro-intestinal
    • Symptôme - Anorexie
  • Oeil
    • Symptôme - Dilatation de la pupille
  • Systèmes nerveux et musculaire
    • Symptôme - Réveil difficile

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.

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

Not recovered / Non 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

Caller applied the product to her 2 dogs that were heavily infested with fleas yesterday morning, 7-17-07. "Koda"-a male 2 year old 110# Lab mix developed severe scratching/itching, pupils dilated, loss of appetite, not wanting to drink much water, not willing to get up and walk or lift his head, scratching himself that he has a bleeding sore on his back that is oozing and has hair loss. He had been bathed with soap and water and then an oatmeal bath yesterday . "Tanna" a female 2 year old 90# Lab mix developed symptoms of severe scratching/itching, not willing to get up and move around much, pupils dilated, and not eating much food or drinking water. She had been bathed with soap and water and then an oatmeal bath yesterday. Caller states the product DID NOT work! Caller has a Vet appt on Friday, 7-20-07 to evaluate/treat the dogs. NOTE: Caller contacted her Veterinarian and was told by the that the product she applied to both dogs was not approved for Veterinary use in Canada. They recommend to bath the dogs. Her Veterinarian told her to come in for Capstar tablets to remove the fleas quickly and then apply Revolution to both of them. Caller again repeated that her Veterinarian and 5 other Veterinarians told her the product is NOT approved for dogs in Canada Caller did admit she bought it in Canada at a local store and (name) stated to the caller if a product was not approved to be sold in this store then the product would not have been on the store shelf. Caller went on to ask "why is this product still on the market, how can this product be used on dogs if these symptoms on her dog's developed, etc.," she described and she went on and on with more to say. Assessment: Discussed with the caller that the 2 dog's symptoms will be documented for (name). This product may cause a slight skin irritation. Product contains a pyrethyroid which may cause a parathesia or "pins and needles" effect such as a burning/tingling sensation to the skin. - The feeling of the animal being uncomfortable may cause behavior changes such as: excessive scratching, neck and back rolling on the floor, vocalization or agitation. If the animal has been excessively scratching it may be difficult to determine if the visible changes to the skin such as erythema are the result of the scratching or from true dermatitis from the product. - True parathesias typically do not result in any visible changes to the skin's appearance. - Symptoms typically resolve on their own in 2-48 hrs. - Some of the symptoms as reported and described are not typical of the product. Additional information provided by (name): Gave new symptoms, the dogs eyes were not red, but the pupils are dilated.


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

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Propriétaire de l'animal

2.Type d'animal touché

Dog / Chien

3. Race

Mixed Breed

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

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

2

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

110

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

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

11. Énumérer tous les symptômes

Système

  • Oeil
    • Symptôme - Dilatation de la pupille
  • Peau
    • Symptôme - Hémorragie
    • Symptôme - Irritation de la peau
  • Système gastro-intestinal
    • Symptôme - Anorexie
  • Peau
    • Symptôme - Perte de cheveux

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.

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

Not recovered / Non 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

Caller applied the product to her 2 dogs that were heavily infested with fleas yesterday morning, 7-17-07. "Koda"-a male 2 year old 110# Lab mix developed severe scratching/itching, pupils dilated, loss of appetite, not wanting to drink much water, not willing to get up and walk or lift his head, scratching himself that he has a bleeding sore on his back that is oozing and has hair loss. He had been bathed with soap and water and then an oatmeal bath yesterday . "Tanna" a female 2 year old 90# Lab mix developed symptoms of severe scratching/itching, not willing to get up and move around much, pupils dilated, and not eating much food or drinking water. She had been bathed with soap and water and then an oatmeal bath yesterday. Caller states the product DID NOT work! Caller has a Vet appt on Friday, 7-20-07 to evaluate/treat the dogs. NOTE: Caller contacted her Veterinarian and was told by the that the product she applied to both dogs was not approved for Veterinary use in Canada. They recommend to bath the dogs. Her Veterinarian told her to come in for Capstar tablets to remove the fleas quickly and then apply Revolution to both of them. Caller again repeated that her Veterinarian and 5 other Veterinarians told her the product is NOT approved for dogs in Canada Caller did admit she bought it in Canada at a local store and (name) stated to the caller if a product was not approved to be sold in this store then the product would not have been on the store shelf. Caller went on to ask "why is this product still on the market, how can this product be used on dogs if these symptoms on her dog's developed, etc.," she described and she went on and on with more to say. Assessment: Discussed with the caller that the 2 dog's symptoms will be documented for (name). This product may cause a slight skin irritation. Product contains a pyrethyroid which may cause a parathesia or "pins and needles" effect such as a burning/tingling sensation to the skin. - The feeling of the animal being uncomfortable may cause behavior changes such as: excessive scratching, neck and back rolling on the floor, vocalization or agitation. If the animal has been excessively scratching it may be difficult to determine if the visible changes to the skin such as erythema are the result of the scratching or from true dermatitis from the product. - True parathesias typically do not result in any visible changes to the skin's appearance. - Symptoms typically resolve on their own in 2-48 hrs. - Some of the symptoms as reported and described are not typical of the product. Additional information provided by (name): Gave new symptoms, the dogs eyes were not red, but the pupils are dilated.


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