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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2009-5006

2. Registrant Information.

Registrant Reference Number: 090095202

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-AUG-09

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

22-AUG-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. 2724-404

Product Name: Vet Kem Ovitrol Plus Flea Tick and Bot Spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .27 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration .62 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .37 %
    • PYRETHRINS
      • Guarantee/concentration .2 %

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 August 22, 2009 the pet owner soaked the puppy to treat a flea infestation. The puppy was sprayed again the next day. The owner also applied a spot on flea and tick preventative that same day.

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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Smooth Collie

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.17

7. Weight (provide a range if necessary )

3.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

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 - Diarrhea
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Unresponsive
    • Specify - Unresponsive
  • 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?

Unknown

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 APSS veterinarian recommended that the pet owner take the puppy to the veterinarian and have the veterinarian call for information. The pet owner took the puppy to an emergency veterinarian that same day. The emergency veterinarian provided fluid therapy. On August 24, 2009 the pet owner contacted the APSS to report that the puppy's signs persisted. The APSS veterinarian recommended that the pet owner take the puppy to the regular veterinarian. The pet owner took the dog to the regular veterinarian. The regular veterinarian administered meloxicam, penicillin, dexamethasone, gastrointestinal (GI) protectants, and provided fluid therapy. On August 25, 2009, the owner took the puppy to the regular veterinarian again due to persisting symptoms. On August 26, 2009 the regular veterinarian contacted the APSS. The APSS veterinarian stated to the regular veterinarian that alcohol intoxication would be possible with this exposure, but signs would not be expected to last for more than 48-72 hours. She recommended that the regular veterinarian provide a diagnostic evaluation and continue with symptomatic and supportive treatment.


To be determined by Registrant

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

Death

19. Provide supplemental information here

On September 1, 2009 an APSS technician spoke to the pet owner who stated that the puppy died. The pet owner disconnected before further information could be obtained. Later that same day, the APSS technician spoke to the regular veterinarian who stated that the puppy died on August 28, 2009. The regular veterinarian performed a gross necropsy on the puppy which revealed a moderately inflamed and irritated duodenum. The regular veterinarian was suspicious that Canine coronavirus may have been the cause of death. The product was not used according to label directions: do not use on cats and dogs under 12 weeks of age.