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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-1017

2. Registrant Information.

Registrant Reference Number: 160167789

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.

10-NOV-16

5. Location of incident.

Country: UNITED STATES

Prov / State: LOUISIANA

6. Date incident was first observed.

08-NOV-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-485-270

Product Name: Adams Plus Flea and Tick Shampoo With Precor For Cats Kittens Dogs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.5 %
    • PYRETHRINS
      • Guarantee/concentration .15 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 November 8, 2016 the owner bathed the kitten in the shampoo.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

4.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Respiratory System
    • Symptom - Dyspnea
    • Specify - Abnormal breathing
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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 November 8, 2016 the owner noticed the kitten was lethargic. On November 9, 2016 the owner noticed the kitten had abnormal breathing (shallow breathing) so the owner put the kitten in the bathroom with a litter box and the morning of November 10, 2016 the owner found the kitten dead. The owner stated that there was nothing in the bathroom that the kitten could have gotten into and the owner had an appointment with a veterinarian that day since the kitten had not been seen by a veterinarian yet (owner had gotten the kitten 3 days prior). The APSS veterinarian stated in general flea shampoos are well tolerated by kittens. The APSS veterinarian stated this clinical picture is not a common presentation of an adverse event to the ingredients. The APSS veterinarian recommended a necropsy, having the veterinarian call for information, and calling back with questions.


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 November 10, 2016 an APSS technician sent the necropsy forms to the veterinary clinic. On November 17, 2016 the interim report for the necropsy was received. The morphologic diagnoses revealed the liver was diffuse marked, hepatic lipodsis; the gastrointestinal tract showed marked, endoparasitism with numerous nematodes consistent with toxocara sp. The interm necropsy comments stated gross findings are consistent with marked hepatic lipidosis, most likely related to hyporexia and nutritional deficits. It is suggested that the heavy nematodiasis observed in this case may have contributed to a systemic debilitating condition. Histopathology will be performed and results are pending.