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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-3990

2. Registrant Information.

Registrant Reference Number: 10-01-22859696

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

Address: 100 Stone Road West, Suite 111

City: Guelph

Prov / State: ON

Country: Canada

Postal Code: N1G 5L3

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

Domestic Animal

4. Date registrant was first informed of the incident.

02-JUN-10

5. Location of incident.

Country: UNITED STATES

Prov / State: ARKANSAS

6. Date incident was first observed.

30-MAY-10

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. 2724-504-2596

Product Name: Ultraguard Pro Flea and Tick Drops for Cats 5 Lbs 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.

.06

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).

Product was applied to pet on May 29th. An unknown product was also purchased for a dog that is in the home so it is possible that the cat was exposed to a dog product.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

.69

7. Weight (provide a range if necessary )

9

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Abnormal posture
    • Specify - stretched out posture
    • Symptom - Ataxia
  • General
    • Symptom - Vocalizing
    • Symptom - Abnormal behaviour
    • Specify - walking in circles
    • 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?

1

Day(s) / Jour(s)

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

The pet was taken to the DVM and bathed at the clinic, given activated charcoal, iv fluids, robaxin rectally, and 2 separate doses of valium. The Prosar specialist recommended that hair testing be offered to confirm the applied product and the DVM to continue symptomatic and supportive care, while looking for the underlying cause for this cat's illness.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The kitten never responded to treatment and died on June 2nd. It is not known if a necropsy was performed. According to the specialist at Prosar, the syndrome described in this cat is not expected due to both it's latency and its severity.