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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2020-0587

2. Registrant Information.

Registrant Reference Number: 2019-US-029792

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.

30-OCT-19

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

6. Date incident was first observed.

28-OCT-19

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. 2724-803-270

Product Name: Adams Flea and Tick Spray for Cats and Dogs

  • Active Ingredient(s)
    • (S)-METHOPRENE
      • Guarantee/concentration .1 %
    • ETOFENPROX
      • Guarantee/concentration .25 %
    • PIPERONYL BUTOXIDE
      • Guarantee/concentration .75 %

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).

Please refer to17 of subform III for a detailed description regarding application.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.33

7. Weight (provide a range if necessary )

2.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Respiratory System
    • Symptom - Dyspnea
  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Unresponsive
  • General
    • Symptom - Hypothermia
  • Gastrointestinal System
    • Symptom - Anorexia
  • Renal System
    • Symptom - Lack of control of urination
  • Gastrointestinal System
    • Symptom - Fecal incontinence
  • Cardiovascular System
    • Symptom - Abnormally slow heart rate
  • General
    • Symptom - Death
    • Symptom - Adipsia
  • Nervous and Muscular Systems
    • Symptom - Other
    • Specify - Limp

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 28-Oct-2019, the animal owner applied the product to the cat to treat existing fleas. During product application, the cat developed dyspnea. Approximately 3-4 hours after application this cat appeared unresponsive, lethargic, and limp to the animal owner. A few hours after these signs developed this cat was evaluated by a veterinarian. This cat was hypothermic and treated with warming measures and IV fluids. The animal owner elected to bring the cat home for monitoring and declined ongoing medical treatment and hospitalization. On 30-Oct -2019 the cat developed a slow heart rate, had urinary and fecal incontinence, anorexic and adipsic. The veterinarian was unable to provide a diagnosis for the cat's symptoms to the animal owner but did not think that the product was the cause. On 7-Nov-2019 the animal owner reported that this cat had died. According to the animal owner the veterinarian thought the clinical signs may have been due to rabies (the pets in the household were not fully vaccinated) but testing for rabies was negative. Three other cats and one dog were also treated with the product in this household at the same time. The other 2 cats and 1 dog remained asymptomatic. The deceased cat and other symptomatic cat were placed together in a kennel following treatment. The other animals were separated following treatment. Animal owner had used the product previously on their pets without development of symptoms.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Assessment: This product has a wide margin of safety when applied as labeled. The active ingredients are present in low concentration and are poorly absorbed across intact skin following topical use. If ingested, minor oral or gastric irritation may occur and result in signs including hypersalivation and vomiting. If inhaled, transient cough or respiratory irritation may occur. The type and severity of clinical signs including this cat's death are not expected from this product's use. It is noted that prior use of the product did not result in adversity and three other treated pets in the home remained asymptomatic. Also, the treating veterinarian reportedly did not suspect the product as the cause of the cat's signs. Other causes for the clinical signs including exposure to additional products, infection, feline asthma, congenital disease, cardiac disease, and malnutrition should be considered. Reports directly from the veterinarian and necropsy could have provided further information, but is not available and / or was not performed. The information contained in this report is based on self-reported statements provided to the registrant during telephone Interview(s). These self-reported descriptions of an incident have not been independently verified to be factually correct or complete descriptions of the incident. For that reason, information contained in this report does not and cannot form the basis for a determination of whether the reported clinical effects are causally related to exposure to the product identified in the telephone interviews.