Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7518

2. Registrant Information.

Registrant Reference Number: 160106649

Registrant Name (Full Legal Name no abbreviations): Wellmark International

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: Ontario

Country: Canada

Postal Code: N1G5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

21-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

12-JUL-16

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. 2724-829-89459

Product Name: Adams Pentagon Flea and Tick Spot on for Large Dogs Puppies 31-60 lbs

• Active Ingredient(s)
  • (S)-METHOPRENE
    • Guarantee/concentration .23 %
  • ETOFENPROX
    • Guarantee/concentration 50 %
  • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • Guarantee/concentration .91 %
  • PIPERONYL BUTOXIDE
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .45 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.149

Units: oz (fl) / oz (liquide)

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).

On July 10, 2016 the owner applied the product onto the four dogs for prevention and on July 11, 2016 the owner brushed the dogs' coats.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Parson Russell Terrier

4. Number of animals affected

4

5. Sex

Male

Female

6. Age (provide a range if necessary )

0.583

7. Weight (provide a range if necessary )

50.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• Skin
  • Symptom - Rash
  • Symptom - Pruritus
  • Symptom - Dermatitis

• General
  • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

Unknown

14. a) Was the animal hospitalized?

Unknown

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 July 12, 2016 the dogs developed symptoms. A few hours later the owner bathed (dish washing liquid (DWL) the dogs and gave them chorpheniramine (owner used to work at a veterinary clinic and knows the appropriate doses). On July 21, 2016 the owner contacted the Animal Product Safety Service (APSS) and sent pictures to the email box. The owner was convinced that the cause of the signs was the product and stated she had used Bio Spot in the past with no issues. The APSS assistant called the owner back after reviewing the pictures and consulting with the APSS veterinarian. The APSS veterinarian stated significant clinical signs are not expected. The APSS veterinarian also stated a dermal hypersensitivity reaction is possible though; clinical signs may include hyperesthesia and mild dermatitis. The owner stated the dogs in between calls with the APSS had developed dermatitis. The APSS assistant recommended taking the dogs to the veterinarian, having the veterinarian call for information, calling back with questions, and having a skin scraping done. The owner also stated that she will use essential oils from now on, once their skin heals. The APSS assistant recommended running the recipe by the attending veterinarian since they can be toxic.

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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

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On August 27, 2016 the owner called the APSS back to state that the dogs had died. She stated that one was real bad and was taken to the veterinarian, where it was suggested it might be parvo. The owner gave the dogs activated charcoal (owner gave charcoal capsules) and milk (owner gave goat milk and colostrum) at an unknown date and time. The APSS veterinarian provided information (we will report the case to the manufacturer) and was unable to have an intelligent conversation with the owner. The APSS veterinarian recommended a necropsy. On August 29, 2016 an APSS technician attempted to contact the owner to discuss necropsy and find out if the bodies were available for necropsy. The APSS technician left a message asking the owner to call the APSS back if the bodies had been kept cool.