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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2010-0197

2. Registrant Information.

Registrant Reference Number: 090101729

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.

09-SEP-09

5. Location of incident.

Country: CANADA

Prov / State: BRITISH COLUMBIA

6. Date incident was first observed.

08-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. 21206      PMRA Submission No.       EPA Registration No.

Product Name: Vet Kem Ovitrol Plus for Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

7. b) Type of formulation.

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 September 8, 2009 the regular veterinarian applied the product heavily 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?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Pomeranian

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.67

7. Weight (provide a range if necessary )

10.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Symptom - Other
    • Specify - Sedate
    • Symptom - Ataxia
  • Cardiovascular System
    • Symptom - Bradycardia
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Depression
    • Symptom - Disorientation
  • General
    • Symptom - Weakness

12. How long did the symptoms last?

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

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?

Unknown

15. Outcome of the incident

Fully Recovered / Complètement rétabli

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 September 9, 2009 the dog was no longer symptomatic. On September 9, 2009 the pet owner took the dog to the veterinarian. The APSS veterinarian stated that pyrethrin and methoprene have wide margins of safety; however, this is an alcohol-based spray so excessive use can lead to dermal absorption of alcohol. In addition, confinement to a small space could lead to inhalation of alcohol vapors and signs of alcohol toxicosis such as sedation, ataxia, and respiratory depression. The APSS veterinarian recommended that the regular veterinarian monitor the dog at the clinic for central nervous system signs, monitor cardiovascular function, monitor body temperature, and monitor for respiratory signs. The APSS veterinarian also recommended that the regular veterinarian provide fluid therapy, give vitamin B, provide symptomatic and supportive care, call with questions, and have the pet owner verify if there is any medication the dog could have been exposed to.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

On September 16, 2009 an APSS technician received a fax from the regular veterinarian which stated that the dog was monitored at the clinic on intravenous fluids, symptomatic and supportive care were provided, and a chemistry panel, complete blood cell count, and electrolyte panel was within normal limits. The patient made a full recovery on September 10, 2009.