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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-5696

2. Registrant Information.

Registrant Reference Number: 1-26541306

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.

17-JUN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: OKLAHOMA

6. Date incident was first observed.

13-JUN-11

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: Hartz UltraGuard Pro Flea and Tick Drops for 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).

Product was applied on June 13th, 2011.

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

Cat Domestic Shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

1

7. Weight (provide a range if necessary )

7.10

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

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Inappropriate defecation
  • General
    • Symptom - Fever
  • Gastrointestinal System
    • Symptom - Weight loss
    • Specify - very thin
  • General
    • Symptom - Other
    • Specify - dry mucous membranes
    • Symptom - Dehydration
  • Nervous and Muscular Systems
    • Symptom - Depression
  • Renal System
    • Symptom - Other
    • Specify - kidney function is not great
  • General
    • Symptom - Hyperthermia
  • 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?

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

DVM saw the cat for the first time on June 17th, 2011. He said that owner had applied product to the cat 5 days ago and owner explained that the next day (June 13th) the cat was symptomatic. The cat was presented to DVM on June 17th, 2011 with a temperature of 105.3, very thin, and the MM were dry. The DVM was asked if cat had been bathed and he said the owner had not. DVM was told to do a thorough bathing even though the cat's syndrome is likely unrelated to the product.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The cat died on June 19th, 2011. DVM asked for necropsy submission forms. The DVM gave the following course of the animal's illness: He indicates the animal was empirically treated with Cefazolin, Zenequin, SQ fluids and force feeding. He reports the animal serum chemistry shortly after he called revealed an elevated BUN 83, Creatinine 2.5, Na140, K 3.2, Ca 7.0, T. bili 4.9. Animals fever persisted (104.3). The animal had a bench top FelV/FIV test which was negative on both accounts. The (name) revealed HCT 37.8, 1035 WBC, HGB 10, RBC 7.3. The owner was offered a referral, but declined. The DVM indicated his differentials included: leptospirosis, tulermia, and hemobartonella. The caller reports on the morning of June 19th, 2011 the animal was found dead in its cage. Per company veterinarian, the product was determined doubtfully related.