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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-7286

2. Registrant Information.

Registrant Reference Number: 130137867

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.

01-OCT-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-OCT-13

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. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Fleatrol Flea and Tick Spray For Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

PMRA Registration No. 26413      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Double Action Flea And Tick Shampoo For Dogs And Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PIPERONYL BUTOXIDE
    • PYRETHRINS

7. b) Type of formulation.

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 September 30, 2013 2 under labelled aged kittens were inappropriately sprayed in the mouth with the spray product and the kittens were inappropriately bathed 3 times that evening with the shampoo product to treat for fleas.

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

Medical Professional

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

2

5. Sex

Unknown

6. Age (provide a range if necessary )

0.14

7. Weight (provide a range if necessary )

750.0

g

8. Route(s) of exposure

Skin

Oral

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Recumbent
    • Specify - Sternal Recumbency
  • Cardiovascular System
    • Symptom - Tachycardia

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown/Inconnu

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 October 1, 2013 the kittens were taken to a shelter veterinarian, and the shelter veterinarian noticed that the kittens were lethargic, sternally recumbent, and tachycardic with a heart rate recorded as 390.0 beats per minute (bpm). The shelter veterinarian gave the kittens fluid therapy right away. A short time later that afternoon the shelter veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that with an oral exposure to the spray product, depression, ataxia, hypoglycemia, and hypothermia could be seen from the carriers; with the shampoo product, dermal irritation could be seen. The APSS veterinarian recommended that the shelter veterinarian monitor the kittens at the facility for central nervous system (CNS) signs, monitor the kittens' body temperature, provide symptomatic and supportive care, provide fluid therapy, provide thermoregulation, perform a diagnostic evaluation, monitor packed cell volume, bathe the kittens with liquid dish washing detergent (LDWD) once they were more stable, call back with questions, and not give activated charcoal.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here

The APSS veterinarian stated that the spray product was considered to have a high likelihood of causing the clinical situation and that the shampoo product was considered to have a low likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected. Therefore, the outcome of this case is unknown. Extra Label Use: Kittens were too young for either application, were sprayed in the mouth and shampooed too frequently.