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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0067

2. Registrant Information.

Registrant Reference Number: 150091904

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.

08-JUL-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-MAY-15

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. 31446      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Power Band Plus Breakaway Dual Action Flea and Tick Collar

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: count

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

Site: Animal / Usage sur un animal domestique

Préciser le type: collar

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

On May 15, 2015 the owner put the collar onto the cat for prevention.

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 Shorthair

4. Number of animals affected

1

5. Sex

Female

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

  • Skin
    • Symptom - Erythema
  • Eye
    • Symptom - Edema
    • Symptom - Discharge eye
    • Symptom - Other
    • Specify - Epiphora
  • Skin
    • Symptom - Discolouration
    • Specify - discoloration of the coat
  • Eye
    • Symptom - Bloodshot eye

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 May 17, 2015 the cat developed erythema, ocular edema, ocular discharge, epiphora, and discoloration of the coat (corner of the eye and fanning out a bit). On May 19, 2015 the cat developed bloodshot eyes. On May 20, 2015 the owner took the cat to the veterinarian, where symptomatic care (eye ointment/cream twice daily (BID) for a little over 7 days) was prescribed. On July 8, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated while some individuals may be sensitive to any topical product, the several day delay suggests that there could have been some other trigger for conjunctivitis. The APSS veterinarian also stated anything that causes excess tears to accumulate on face can lead to the rust colored staining of fur and skin. The APSS assistant recommended taking the cat to the veterinarian (to be re-evaluated) and having the veterinarian call for information.


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 conjunctivitis was considered to have a high likelihood of causing the clinical situation.