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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0006

2. Registrant Information.

Registrant Reference Number: 140153545

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.

03-DEC-14

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

29-NOV-14

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. 26493      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea and Tick Control for Dogs Over 14 kg (30 Lbs)

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

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

2

Units: mL

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 28, 2014 the owner applied the product onto the dog.

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

Dog / Chien

3. Breed

American Pit Bull Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

11.0

7. Weight (provide a range if necessary )

60.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Other
    • Specify - Skin problems
    • Symptom - Pruritus
    • Symptom - Hair loss
    • Symptom - Dermatitis
  • Blood
    • Symptom - Bleeding
    • Specify - serosanguinous discharge and a small amount of blood, which was oozing slowly, not dripping)

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

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 November 29, 2014 the owner noticed at the site of application the dog had skin problems (the fur had become hard and crispy), so they bathed the dog with Dawn dishsoap. On November 30, 2014 the owner noticed the dog developed pruritus, alopecia, and dermatitis (application site is raw and owner noted serosanguinous discharge and a small amount of blood, which was oozing slowly, not dripping). The owner then provided wound management by applying a hot spot spray and bandage. On December 3, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS technician stated the risk is for dermal hypersensitivity and paresthesia. The APSS technician recommended the owner discontinue product usage (hot spray and also agent with permethrin), taking the dog to the veterinarian (immediately for evaluation and treatment of the skin), having the veterinarian call for information.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

Signs expected to be mild and self-limiting.