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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0012

2. Registrant Information.

Registrant Reference Number: 140156824

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.

10-DEC-14

5. Location of incident.

Country: CANADA

Prov / State: NEW BRUNSWICK

6. Date incident was first observed.

04-DEC-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 September 10, 2014 and continuing monthly until December 4, 2014 the owner applied the product onto the dog to treat for 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

Dog / Chien

3. Breed

Beagle Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

10.0

7. Weight (provide a range if necessary )

60.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>2 hrs <=8 hrs / > 2 h < = 8 h

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
    • Specify - Rubbing Application Site
    • Symptom - Hair loss
  • General
    • Symptom - Licking
  • Skin
    • Symptom - Erythema
  • General
    • Symptom - Parasitism
    • Specify - Flea infestation

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 October 4, 2014 and November 4, 2014 the dog had an isolated event of rubbing the application site. On December 4, 2014 the dog developed rubbing of the application site, alopecia (back legs), licking, erythema (anywhere he can lick is raw), and a flea infestation. On December 10, 2014 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dermal reactions are possible. The APSS veterinarian recommended taking the dog to the veterinarian, having the veterinarian call for information, flea treatment (talk with veterinarian about flea allergy and flea control), discontinuing product usage, and calling back with questions.


To be determined by Registrant

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

Minor

19. Provide supplemental information here

The APSS veterinarian stated that flea allergy was considered to have a medium likelihood of causing the clinical situation. Signs expected to be mild and self limiting.