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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5021

2. Registrant Information.

Registrant Reference Number: 090107133

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.

23-SEP-09

5. Location of incident.

Country: UNITED STATES

Prov / State: WISCONSIN

6. Date incident was first observed.

18-SEP-09

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. 2724-796-270

Product Name: Adams Flea and Tick Spot On E30 for Large Dogs 31-80 lbs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration 3.6 %
    • ETOFENPROX
      • Guarantee/concentration 30 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 5 %

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

6

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 September 18, 2009 the owner applied the product to the dog to treat a flea infestation.

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

Dog / Chien

3. Breed

Labrador Retriever

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

70

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

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Gastrointestinal System
    • Symptom - Vomiting
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Adipsia
  • Gastrointestinal System
    • Symptom - Bloody vomit
  • Respiratory System
    • Symptom - Cyanosis
  • 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?

33.5

Hour(s) / Heure(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 owner took the dog to a regular veterinarian on September 21, 2009, where fluids and reglan were given, and bloodwork was done. On September 22, 2009 the dog was transferred to another regular veterinarian's office where the pet had to be carried into the clinic. The regular veterinarian gave Cephalexin and an antihistamine. On September 23, 2009 at 12:00 am CDT, the dog's tongue was purple as the dog was not oxygenating. The dog died on September 23, 2009 at 7:30 am CDT. The APSS veterinarian stated that significant neurologic signs are not expected with the appropriate use of etofenprox. The APSS veterinarian recommended a necropsy, histopath, and toxicology screen.


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 considered to have a doubtful likelihood of causing the clinical situation. Between September 23 and 25, 2009 multiple contacts were made between APSS technicians, APSS contacts, regular vet staff, diagnostic lab staff, and a shipping company to set up the necropsy. On September 25, 2009 a regular veterinarian staff member called to inform us that they would not be sending specimens for necropsy as the body was too deteriorated.