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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7595

2. Registrant Information.

Registrant Reference Number: 170193217

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.

04-NOV-17

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

31-OCT-17

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 October 31, 2017 the owner applied the product to the dog to treat a condition.

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

Labrador Retriever, Rottweiler, Shepherd Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

4.0

7. Weight (provide a range if necessary )

138.0

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 - Dry skin
    • Specify - Dandruff
  • Nervous and Muscular Systems
    • Symptom - Ataxia
  • Gastrointestinal System
    • Symptom - Anorexia
  • Nervous and Muscular Systems
    • Symptom - Head tilt
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Agitation
  • General
    • Symptom - Polydipsia

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?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Not recovered / Non rétabli

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 31, 2017 the dog developed dandruff. On November 1, 2017 the dog developed ataxia, anorexia, a head tilt, vocalization, agitation, and polydipsia. The owner then gave the dog a bath (with medicated dandruff shampoo, gave two baths, symptoms continued). On November 4, 2017 the owner took the dog to the regular veterinarian who had to sedate the dog because he was very agitated. The regular veterinarian gave an antihistamine (Benadryl, for two weeks) and sent the owner home with Vanectyl P tablets (for two weeks). Later in the afternoon, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that mild dermal paresthesia may be seen with associated behavioral responses (hiding, whining, rolling, etc). The APSS veterinarian also stated that the wet area after application can accumulate dust, appearing like dandruff, unsure if that is the case in this dog. Finally, the APSS veterinarian stated that some of these signs would not be expected from this product. The APSS assistant recommended the owner monitor at home, give the dog a bath (with Dawn dish soap), apply vitamin E oil to the application site, apply a cold compress, and to call back with questions.


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 substance was considered to have a doubtful likelihood of causing the clinical situation. The APSS veterinarian also stated that head tilting would not be expected and signs would not be expected to be seen a week later. On November 6, 2017 the owner called back to update the case. The owner stated that the dog is still experiencing symptoms but the dandruff, ataxia, head tilt, vocalization, and agitation have become more mild. The APSS veterinarian stated that given the time frame, signs should have resolved by now.