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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3858

2. Registrant Information.

Registrant Reference Number: 110070280

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.

06-JUN-11

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

06-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. 2724-485-270

Product Name: Adams Plus Flea And Tick Shampoo With Precor For Cats Kittens Dogs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.5 %
    • PYRETHRINS
      • Guarantee/concentration .15 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 6, 2011 the owner applied the product to his dog.

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

Dog / Chien

3. Breed

American Eskimo

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.54

7. Weight (provide a range if necessary )

25.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

>15 min <=2 hrs / >15 min <=2 h

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Fecal incontinence
  • Renal System
    • Symptom - Urinary incontinence
  • Respiratory System
    • Symptom - Laboured breathing
    • Specify - Slow Deep Breathing
  • Nervous and Muscular Systems
    • Symptom - Recumbent
  • Gastrointestinal System
    • Symptom - Vomiting
  • Eye
    • Symptom - Other
    • Specify - Absent Palpebral Reflex
  • General
    • Symptom - Death

12. How long did the symptoms last?

Persisted until death

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

No

14. a) Was the animal hospitalized?

No

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 June 6, 2011 while bathing the dog with the product, the dog may have ingested some of the product and became symptomatic. Shortly after the signs began, the owner contacted the Animal Product Safety Service (APSS) to obtain help. During the call, the owner stated the dog did not have a palpebral reflex and the dog was no longer breathing, so it was determined the dog had died. The APSS veterinarian stated that death would not be expected from the use of the product. The APSS veterinarian recommended the owner have a necropsy performed on the dog.


To be determined by Registrant

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

Death

19. Provide supplemental information here

According to the necropsy results, the histological evidence suggests heart failure as the cause of death.