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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-7525

2. Registrant Information.

Registrant Reference Number: 160138087

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.

15-SEP-16

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

30-AUG-16

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 30, 2016 the owner took the cat to the veterinary clinic, where he received a dexamethasone injection (2 milligram (mg) under the skin) for fleas. The attending veterinary clinic also sprayed the cat with the product for fleas.

To be determined by Registrant

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

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

12.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Drooling
  • General
    • Symptom - Hiding
    • 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 August 30, 2016 after getting home from the veterinary clinic, the cat developed symptoms. The owner called the attending veterinarian, who recommended bathing the cat (with Dawn dish soap), which the owner did. Later that evening the cat died. On September 15, 2016 the attending veterinary staff contacted the Animal Product Safety Service (APSS) to discuss the case. The APSS veterinarian stated with the Vet Kem product a number of sprays contain isoproanol as a carrier and if animals are heavily saturated, there can be risks for alcohol intoxication. The APSS veterinarian also stated if ingested, there can be signs of hypersalivation and nausea. The APSS veterinarian stated with the dexamethosone it is a corticosteriod and with an acute overdose, we rarely see any significant clinical signs. The APSS veterinarian also stated may see gastrointestinal (GI) upset, polyuria and polydipsia (PU/PD), polyphagia. The APSS veterinarian finally stated dexamethasone doesn't have mineralocorticoid activity. The APSS veterinarian stated a necropsy would not be possible as the death had occurred too long ago.


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 dexamethasone injection was considered to have a doubtful likelihood of causing the clinical situation.