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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6503

2. Registrant Information.

Registrant Reference Number: 130128018

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.

11-SEP-13

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

10-SEP-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. 28199      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerband Plus Dual Action Flea and Tick Collar for Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • PROPOXUR

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 10, 2013 the owner placed the flea and tick collar on the cat to prevent fleas.

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Mediumhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7.0

7. Weight (provide a range if necessary )

9.5

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

  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Symptom - Abnormal feces colour
  • General
    • Symptom - Jaundice
  • Gastrointestinal System
    • Symptom - Vomiting
  • Renal System
    • Symptom - Inappropriate urination
  • Nervous and Muscular Systems
    • Symptom - Unresponsive
  • General
    • Symptom - Dehydration
  • Gastrointestinal System
    • Symptom - Weight loss
    • Specify - Emaciation
  • Blood
    • Symptom - Anemia

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?

Unknown

14. b) How long was the animal hospitalized?

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 September 10, 2013 the owner noticed that the cat was lethargic and inappetent. On September 11, 2013 the owner noticed that the cat's feces were an abnormal color and the cat had icterus, with his gums and the skin around his ears and face appearing yellow. The owner removed the flea and tick collar a short time later, and the owner noticed that the cat was no longer lethargic or inappetent. Later that evening the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that Propoxur has a good margin of safety and that systemic effects leading to icterus would not be expected. The APSS assistant recommended that the owner take the cat to the veterinarian, have the veterinarian call for information, and call back with questions.


To be determined by Registrant

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

Major

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation. On September 12, 2013 the owner's regular veterinarian contacted the APSS to update the case. The APSS veterinarian recommended that the owner's regular veterinarian perform a diagnostic evaluation and provide symptomatic care. On September 13, 2013 the owner called the APSS to update the case. The owner stated that the cat tested positive for the feline leukemia virus (FeLV) on September 12, 2013. The cat was given Baytril that evening and again 12 hours later on the morning of September 13, 2013. The owner also stated that the cat was lethargic, vomiting, urinating inappropriately, and unresponsive on the evening of September 13, 2013. The APSS veterinarian stated that only mild gastrointestinal (GI) upset would be expected with the exposure to the Baytril. The APSS veterinarian recommended that the owner take the cat to a veterinarian right away. The APSS veterinarian stated that the Baytril was considered to have a doubtful likelihood of causing the clinical situation and that the feline leukemia virus was considered to have a high likelihood of causing the clinical situation. Later on the evening of September 13, 2013 the owner's emergency veterinarian contacted the APSS to update the case. The emergency veterinarian stated that the cat was dehydrated, emaciated, and anemic, with a hematocrit recorded as 18.0 percent by volume (% v/v). The APSS veterinarian recommended that the emergency veterinarian do a differential blood smear, potentially send for a hemobartonella titer, continue providing symptomatic care, and call back with questions.