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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6477

2. Registrant Information.

Registrant Reference Number: 130099587

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.

19-JUL-13

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

6. Date incident was first observed.

12-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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 2724-813

Product Name: Vet Kem Ovitrol X-Tend Flea And Tick Spot On Large Cats 5lbs and over

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 40 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

1.8

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).

On June 28, 2013 the owner applied the product to the cat to prevent fleas.

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 Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.5

7. Weight (provide a range if necessary )

8.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • Eye
    • Symptom - Irritated eye
    • Symptom - Other
    • Specify - Bulging Eyes
    • Symptom - Dry eye
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Blood
    • Symptom - Anemia
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

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, 2013 the owner noticed that the cat was symptomatic. On July 18, 2013 the owner took the cat to the veterinarian, where the cat was sedated, his eye was cleaned, and an unknown injectable medication was given; the pet was monitored at the clinic for an unknown amount of time. On July 19, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that when a spot on product is used, it is possible that an individual might have an adverse reaction or hypersensitivity that would be expected within a few hours; if the product was applied in the eye, a reaction would be noted within minutes, not days. The APSS technician recommended that the owner have her regular veterinarian call for information and referred the owner to the product's manufacturer to discuss reimbursement.


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 not considered to be related to causing the clinical situation. On September 10, 2013 the owner contacted the APSS to update the case. The owner stated that the cat remained symptomatic and that on September 3, 2013 the cat was anorexic and anemic. On September 4, 2013 the owner took the cat to her regular veterinarian, where a diagnostic examination revealed that the cat was anemic; at the clinic the cat was given HiVite Drops and the owner was sent home with a special diet to be fed via syringe. The owner stated that the cat died early on the morning of September 10, 2013. The owner had already buried the cat earlier that day, but the APSS veterinarian mentioned the owner might wish to preserve the body for a necropsy. The APSS veterinarian recommended that the owner have her regular veterinarian call to discuss a necropsy. At this time it is unknown whether a necropsy will be pursued.