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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0224

2. Registrant Information.

Registrant Reference Number: 160028672

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.

29-FEB-16

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

6. Date incident was first observed.

29-FEB-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. 2724-490

Product Name: Vet Kem Siphotrol Plus II Premise Spray

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .085 %
    • D-PHENOTHRIN
      • Guarantee/concentration .3 %
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
      • Guarantee/concentration 2 %
    • PERMETHRIN
      • Guarantee/concentration .35 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration 1.4 %

7. b) Type of formulation.

Other (specify)

aerosol

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Res. - In Home / Rés. - à l'int. maison

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

On February 15, 2016 the owner sprayed the premises with the product. The cat was not in the room during the spraying and did not have access to the room for several hours.

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 Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

9.0

7. Weight (provide a range if necessary )

7.0

lbs

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Dehydration
  • Blood
    • Symptom - Anemia
  • Renal System
    • Symptom - Other
    • Specify - Renal Disease
  • Nervous and Muscular Systems
    • Symptom - Muscle twitching
    • Specify - Facial Twitching
    • Symptom - Recumbent
    • Specify - Sternal Recumbency
  • Blood
    • Symptom - Other
    • Specify - Elevated Blood Urea Nitrogen
  • General
    • Symptom - Other
    • Specify - Hyperphosphatemia
    • Symptom - Hypothermia
  • Nervous and Muscular Systems
    • Symptom - Seizure
  • Cardiovascular System
    • Symptom - Cardiac arrest
  • 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?

Unknown

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Died

16. How was the animal exposed?

Contact treat.area/Contact surf. traitée

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

On February 29, 2016 the cat developed lethargy, anorexia, and dehydration. Later that day, the owner took the cat to the veterinarian, where a chemistry profile, complete blood count, and monitoring electrolytes were performed and the cat was given atropine. Later that day, the cat was diagnosed with anemia, with a hematocrit of 14.2 percent volume to volume (% v/v), renal disease, with serum creatinine of 2.4 mg/dL, elevated blood urea nitrogen, with blood urea nitrogen of 104.0 milligrams per deciliter (mg/dL), and hyperphosphatemia, with serum phosphorus of 0.0 mg/dL (high unmeasurable). The cat's dehydration worsened and the cat developed facial twitching, sternal recumbency, and hypothermia, with a temperature of 95.3 degrees Fahrenheit (deg F). Shortly after the attending veterinarian called the Animal Product Safety Service (APSS). The APSS veterinarian stated the active ingredients are pyrethroids, which often cause gagging, retching, lip licking, increased swallowing, and vomiting from the tingling/burning sensation in the mouth and throat. The APSS veterinarian also stated these signs often occur right after exposure, and are usually self-limiting. The APSS veterinarian further stated that central nervous system (CNS) signs are not expected. The APSS veterinarian recommended a diagnostic evaluation, fluid therapy (correct hydration), blood transfusion, treat renal failure, supportive and symptomatic care, and calling back with questions.


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. On March 1, 2016 the attending veterinarian called the APSS back. The attending veterinarian stated the cat was given fluid therapy at an unknown time. The attending veterinarian also stated that the cat was showing some improvement that morning and was given atropine. A few hours later the cat had a seizure, was given diazepam (1.25 mg), went into cardiac arrest and died. About an hour later the attending veterinarian called the APSS to further discuss the case. The attending veterinarian stated the cat's owner has other cats that have been treated for flea anemia and she has used this product in the past. The APSS veterinarian discussed the signs that could develop if there was access to the wet spray and anemia and acute kidney injury (AKI) are not expected from the product. The APSS veterinarian recommended a necropsy. The attending veterinarian stated she would discuss the necropsy with the owner.