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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0186

2. Registrant Information.

Registrant Reference Number: 160055159

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.

20-APR-16

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

16-APR-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. 28598      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Ovitrol Dual Action Collar For Cats And Kittens

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PROPOXUR

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 April 15, 2016 the owner applied the collar onto the cat for prevention.

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

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

4.0

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
    • Symptom - Adipsia
  • Gastrointestinal System
    • Symptom - Vomiting
  • Blood
    • Symptom - Leukopenia
    • Symptom - Other
    • Specify - Toxic Neutrophils
  • Skin
    • Symptom - Jaundice
  • Blood
    • Symptom - Hyperbilirubinemia
    • Symptom - Other
    • Specify - Elevated Amylase

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Unknown/Inconnu

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 April 16, 2016 the cat developed anorexia, adipsia, and lethargy, so the owner removed the collar. On April 17, 2016 the cat began vomiting. On April 18, 2016 the owner took the cat to the veterinarian where the cat was hospitalized and started on fluid therapy (given for a couple days), manage vomiting (given an injection) and stimulate appetite (an injection given) and had complete blood count (CBC) which noted the cat had developed leukopenia, toxic neutrophils, icterus, hyperbilirubinemia, and elevated amylase. On April 19, 2016 the cat was given another injection to stop vomiting as well as an antacid and was force fed by a syringe. On April 20, 2016 the owner called the Animal Product Safety Service (APSS) to determine if the flea collar was the cause of the cat's signs and to ask about compensation for the product. The APSS veterinarian stated propoxur is a carbamate insecticide that is often used in flea collars for dogs and cats, when used per label it has a wide margin of safety. The APSS veterinarian also stated if the collars are chewed or ingested, signs of hypersalivation, vomiting, possibly diarrhea, and ataxia may occur but are usually transient. The APSS veterinarian finally stated some animals may have behavioral changes if they are not used to wearing collars, but severe signs are not expected. The APSS veterinarian recommended continuing treatment, having the veterinarian call for information, and a referral to the manufacturer (about reimbursement).


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.