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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6697

2. Registrant Information.

Registrant Reference Number: 1-34388213

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.

23-JUL-13

5. Location of incident.

Country: UNITED STATES

Prov / State: MAINE

6. Date incident was first observed.

Unknown

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).

Owner inappropriately applied the wrong dose of product to under labelled weight kitten on July 19, 2013.

To be determined by Registrant

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

No

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

Female

6. Age (provide a range if necessary )

.38

7. Weight (provide a range if necessary )

4.9

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Vomiting
    • Symptom - Diarrhea
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • 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

On July 19th, 2013 the owner applied product to the kitten and it became symptomatic at unknown time. The caller (a vet tech) reports that on July 21 2013 the kitten was examined and prescribed oral medications and fluids. The owner brought in the kitten as she found it had died some time in the night of July 22, 2013


To be determined by Registrant

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

Death

19. Provide supplemental information here

Staff veterinarian determined to be doubtfully related to product use. Necropsy results indicated thin cat with significant flea infestation. Poor body condition is suggestive of chronic anorexia.