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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-1019

2. Registrant Information.

Registrant Reference Number: 160171369

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.

17-NOV-16

5. Location of incident.

Country: UNITED STATES

Prov / State: MICHIGAN

6. Date incident was first observed.

14-NOV-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: Zodiac Fleatrol Flea and Tick Spray for Dogs Cats Puppies and Kittens

  • 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 November 14, 2016 the owner sprayed the geriatric dog with the product to treat 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

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

12.0

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Anorexia
  • General
    • Symptom - Abnormal behaviour
    • Specify - Behavior Change
    • Symptom - Vocalizing
  • Gastrointestinal System
    • Symptom - Drooling
  • 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?

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 November 14, 2016 the dog developed ataxia and lethargy. On November 15, 2016 the owner bathed the dog (with baby shampoo). On November 17, 2016 the dog developed anorexia. A few hours later the dog developed a behavior change and vocalization. The owner then contacted the Animal Product Safety Service (APSS). The APSS technician stated if ingested, there can be signs of hypersalivation and nausea. The owner stated she thought the pet may be having a seizure, so the APSS technician recommended taking the dog to the veterinary clinic and having the veterinarian call for information. The APSS technician discussed with the caller about how these sprays can cause mild and self limiting gastrointestinal (GI) upset, but symptoms are not expected to last for days. The APSS technician also stated that there is something going on with the pet that is unrelated to the spray.


To be determined by Registrant

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

Death

19. Provide supplemental information here

The APSS technician stated that the substance was not considered to be related to causing the clinical situation. On November 17, 2016 the owner called the APSS back to update the case. The owner stated the dog was currently at the veterinary clinic and had developed hypersalivation and seizures. The APSS veterinarian recommended having the veterinarian call for information. An hour later, a staff member from the attending veterinary clinic called the APSS to discuss the case. The APSS veterinarian stated that initial salivation and vomiting can be seen if the wet product is ingested; however this would not last 3 days. The APSS veterinarian also stated we would not expect central nervous system (CNS) or systemic signs and stated we need to rule out other causes for the signs. The APSS veterinarian recommended a diagnostic evaluation, supportive and symptomatic care, referral to the manufacturer (to discuss any billing or reimbursement questions), and calling back with questions. On November 20, 2016 the owner returned the APSS's follow-up call. The owner stated that after the attending veterinary staff had spoken with the APSS, the attending veterinarian had given the dog diazepam; the dog stopped seizuring, but went into cardiac arrest and died. The owner was upset as the clinic told her she should have bathed with Dawn liquid dish washing detergent to wash the product off and she wasn't originally told this by APSS. The APSS veterinarian advised the owner that ultimately in this case bathing the dog with Dawnliquid dish washing detergent would not have changed the outcome in this case. On November 21, 2016 the APSS technician contacted the clinic to discuss necropsy or see if the owner took the body home. The attending veterinary staff confirmed that the pet was taken home for burial. It is unknown if a veterinarian was consulted before using this product on the geriatric dog.