Déclaration d'incident

Sous-formulaire I: Renseignements généraux

1.Type de rapport.

Nouvelle déclaration d'incident

No de la demande: 2013-6058

2. Renseignements concernant le titulaire.

Numéro de référence du titulaire d'homologation: 2013-US-06497

Nom du titulaire (nom légal complet, aucune abbréviation): Merck Animal Health (Intervet Canada Corp)

Adresse: 16750 Transcanada Highway

Ville: Kirkland

État: Quebec

Pays: Canada

Code postal /Zip: H9H 4M7

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.

01-AUG-13

5. Lieu de l'incident.

Pays: UNITED STATES

État: FLORIDA

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

07-JUL-13

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. 773 95

Nom du produit: ACTIVYL TICK PLUS

• Matière active
  • INDOXACARB TECHNICAL
  • PERMETHRIN
    • Garantie/concentration 42.5 %

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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.

.5

Unités: mL

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?

Oui

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Professionnel de la santé

2.Type d'animal touché

Dog / Chien

3. Race

German Shepherd

4. Nombre d'animaux touchés

1

5. Sexe:

Homme

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

0.4

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

8.6

lbs

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

<=15 min / <=15 min

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

• Peau
  • Symptôme - Oedème

• Sang
  • Symptôme - Anémie

• General
  • Symptôme - Déshydratation

• Peau
  • Symptôme - Lésion dermale
  • Specify - application site abcess

• General
  • Symptôme - Autre
  • Specify - allergy

• Peau
  • Symptôme - Autre
  • Specify - cellulitis
  • Symptôme - Dermatite
  • Specify - application site scab/crust

• General
  • Symptôme - Vocalisation
  • Symptôme - Autre
  • Specify - hypersensitivity
  • Symptôme - Perte de cheveux
  • Specify - Alopecia

• Système gastro-intestinal
  • Symptôme - Diarrhée

• General
  • Symptôme - Douleur
  • Symptôme - Enflure

• Système respiratoire
  • Symptôme - Autre
  • Specify - dry mucous membranes

12. Quelle a été la durée des symptômes?

>1 mo and <= 2mos / >1 mois et < = 2mois

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

Recvrd resid.effects/Rétabli séquelles

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

On 01 Aug 2013 a veterinarian reported a dog experienced application site swelling, pain, anemia, dehydration and abscess on 07 Jul 2013 and dermatitis, cellulitis and scabbing along the dorsal midline on 15 Jul 2013 while it s litter mate died on 07 Jul 2013 following administration of Activyl Tick Plus for Dogs and Puppies (over 4 lb and up to 11 lb) and Panacur. The pups were adopted from a shelter on 03 Jul 2013. The pups were treated with Activyl Tick Plus, an unknown dose of Panacur, an known manufacturer s DAPPv vaccine, an unknown manufacturer s Bordetella vaccine, an unknown manufacturer s microchip, an unknown dose of Capstar and Adam s Spay on 02 Jul 2013. On 06 Jul 2013 the pups were examined by a veterinarian for new puppy check-up and the records indicated looks good. On 07 Jul 2013 the male pup was presented to an Emergency Clinic at 6 PM with a history of being left outside in the shade in a cage with access to water. When the owner arrived home the female pup was dead and the male pup had pain and swelling in the neck and hind area. No details have been available regarding the dead pup. Physical exam revealed dry mucous membranes, painful swellings between the shoulder blades and over the dorsal hip area. CBC revealed anemia. The vet diagnosed Anemia, dehydration, abscess and allergy. The pup was treated with subcutaneous fluids, Metacam and Clavamox. The pup was presented back to the primary vet on 08 Jul 2013. Fecal float was negative and the pup s temp was 100.3. There was no mention of pain or swelling in records. Examination on 09 Jul 2013 revealed the pup was eating but its stool was a little soft. The pup remained on Clavamox and Metacam. The pup was presented back to the vet on 16 Jul 2013. The owner reported the pup was still painful when picked up and now had a large lesion on its back. Physical exam revealed a 10 cm by 3 cm area of thickened skin along the dog s dorsum. CBC revealed the pup was anemic. The pup s treatments were to switch to Cefpodoxime, Metacam and Tramadol. Histopathology report stated Haired skin Dermatitis and cellulitis, histiocytic, suppurative and lymphoplasmacytic, marked, chronic, generalized with adnexal mineralization, superficial intracorneal neutrophils and periadnexal fibrosis. The basic lesion is of full thickness early dermal necrosis ischemic dermatopathy associated with a cell poor vasculitis vasculopathy. Such change may be the result of a drug reaction, vaccine reaction, or sepsis. There is concern that there may be large vessel involvement that is not present in this one biopsy, leading to dermal infarction therefore, other causes of large vessel thrombotic thromboembolic disease should be considered as well. This should be considered a medical emergency, especially if the lesions are progressive, [Though the] lesions are not primary septic related, they certainly can lead to secondary sepsis. Bacterial culture revealed Staphylococcus pseudointermedius. The pup was making slow improvements on 27 Jul 2013 and remained under treatment at the time of report. More information anticipated. Follow up On 19 Sep 2013 the vet reported that physical exam on 14 Sep 2013 revealed the dog's lesion was healed. The entire lesion along the dog s back had pink hairless skin. All the dog s other signs had resolved except the application site scar. No more information expected.

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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

Sous-formulaire III : Animal domestique

1. Source de la déclaration

Professionnel de la santé

2.Type d'animal touché

Dog / Chien

3. Race

German Sheppherd

4. Nombre d'animaux touchés

1

5. Sexe:

Femme

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

0.4

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

Inconnu

8. Voie(s) d'exposition:

Cutanée

9. Durée de l'exposition?

<=15 min / <=15 min

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?

Unknown / Inconnu

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

On 01 Aug 2013 a veterinarian reported a dog experienced application site swelling, pain, anemia, dehydration and abscess on 07 Jul 2013 and dermatitis, cellulitis and scabbing along the dorsal midline on 15 Jul 2013 while it s litter mate died on 07 Jul 2013 following administration of Activyl Tick Plus for Dogs and Puppies (over 4 lb and up to 11 lb) and Panacur. The pups were adopted from a shelter on 03 Jul 2013. The pups were treated with Activyl Tick Plus, an unknown dose of Panacur, an known manufacturer s DAPPv vaccine, an unknown manufacturer s Bordetella vaccine, an unknown manufacturer s microchip, an unknown dose of Capstar and Adam s Spay on 02 Jul 2013. On 06 Jul 2013 the pups were examined by a veterinarian for new puppy check-up and the records indicated looks good. On 07 Jul 2013 the male pup was presented to an Emergency Clinic at 6 PM with a history of being left outside in the shade in a cage with access to water. When the owner arrived home the female pup was dead and the male pup had pain and swelling in the neck and hind area. No details have been available regarding the dead pup. Physical exam revealed dry mucous membranes, painful swellings between the shoulder blades and over the dorsal hip area. CBC revealed anemia. The vet diagnosed Anemia, dehydration, abscess and allergy. The pup was treated with subcutaneous fluids, Metacam and Clavamox. The pup was presented back to the primary vet on 08 Jul 2013. Fecal float was negative and the pup s temp was 100.3. There was no mention of pain or swelling in records. Examination on 09 Jul 2013 revealed the pup was eating but its stool was a little soft. The pup remained on Clavamox and Metacam. The pup was presented back to the vet on 16 Jul 2013. The owner reported the pup was still painful when picked up and now had a large lesion on its back. Physical exam revealed a 10 cm by 3 cm area of thickened skin along the dog s dorsum. CBC revealed the pup was anemic. The pup s treatments were to switch to Cefpodoxime, Metacam and Tramadol. Histopathology report stated Haired skin Dermatitis and cellulitis, histiocytic, suppurative and lymphoplasmacytic, marked, chronic, generalized with adnexal mineralization, superficial intracorneal neutrophils and periadnexal fibrosis. The basic lesion is of full thickness early dermal necrosis ischemic dermatopathy associated with a cell poor vasculitis vasculopathy. Such change may be the result of a drug reaction, vaccine reaction, or sepsis. There is concern that there may be large vessel involvement that is not present in this one biopsy, leading to dermal infarction therefore, other causes of large vessel thrombotic thromboembolic disease should be considered as well. This should be considered a medical emergency, especially if the lesions are progressive, [Though the] lesions are not primary septic related, they certainly can lead to secondary sepsis. Bacterial culture revealed Staphylococcus pseudointermedius. The pup was making slow improvements on 27 Jul 2013 and remained under treatment at the time of report. More information anticipated. Follow up On 19 Sep 2013 the vet reported that physical exam on 14 Sep 2013 revealed the dog's lesion was healed. The entire lesion along the dog s back had pink hairless skin. All the dog s other signs had resolved except the application site scar. No more information expected.

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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