Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6058

2. Registrant Information.

Registrant Reference Number: 2013-US-06497

Registrant Name (Full Legal Name no abbreviations): Merck Animal Health (Intervet Canada Corp)

Address: 16750 Transcanada Highway

City: Kirkland

Prov / State: Quebec

Country: Canada

Postal Code: H9H 4M7

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

01-AUG-13

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

07-JUL-13

Product Description

7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.

Active(s)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 773 95

Product Name: ACTIVYL TICK PLUS

• Active Ingredient(s)
  • INDOXACARB TECHNICAL
  • PERMETHRIN
    • Guarantee/concentration 42.5 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.5

Units: mL

10. Site pesticide was applied to (select all that apply).

Site: Animal / Usage sur un animal domestique

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

German Shepherd

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.4

7. Weight (provide a range if necessary )

8.6

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Skin
  • Symptom - Edema

• Blood
  • Symptom - Anemia

• General
  • Symptom - Dehydration

• Skin
  • Symptom - Lesion
  • Specify - application site abcess

• General
  • Symptom - Other
  • Specify - allergy

• Skin
  • Symptom - Other
  • Specify - cellulitis
  • Symptom - Dermatitis
  • Specify - application site scab/crust

• General
  • Symptom - Vocalizing
  • Symptom - Other
  • Specify - hypersensitivity
  • Symptom - Hair loss
  • Specify - Alopecia

• Gastrointestinal System
  • Symptom - Diarrhea

• General
  • Symptom - Pain
  • Symptom - Swelling

• Respiratory System
  • Symptom - Other
  • Specify - dry mucous membranes

12. How long did the symptoms last?

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

13. Was medical treatment provided? Provide details in question 17.

Yes

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Recvrd resid.effects/Rétabli séquelles

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

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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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

German Sheppherd

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.4

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

<=15 min / <=15 min

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Treatment / Traitement

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

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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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here