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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7036

2. Registrant Information.

Registrant Reference Number: 170094883

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.

07-JUN-17

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

01-JUN-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. 31367      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot Flea and Tick Control for Dogs under 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.

1

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 May 31, 2017 the owner applied the product to the dog as 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

Dog / Chien

3. Breed

Bedlington Terrier

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.0

7. Weight (provide a range if necessary )

20.0

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 - Erythema
    • Symptom - Pruritus
  • Nervous and Muscular Systems
    • Symptom - Agitation
  • Skin
    • Symptom - Lesion
    • Specify - Scab

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 June 1, 2017 the dog developed erythema. On June 2, 2017 the owner bathed the dog (with regular dog shampoo). On June 3, 2017 the erythema worsened. On June 6, 2017 the dog developed pruritus, agitation, and a scab on the application site. The owner then rebathed the dog and applied silver sulfadiazine (ASAP 365, Silver Gel). On June 7, 2017 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated that permethrins and pyrethroids can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus. The APSS veterinarian also stated that occasionally animals will develop sores or scabs, and alopecia secondary to scratching or biting the application site. The APSS assistant recommended the owner take the animal to a veterinarian (to evaluate, start supportive cares, and pain control if needed) and have 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

On June 11, 2017 an APSS assistant called the owner for a follow up. The owner stated that the signs continued and that the dog has a follow up appointment with a veterinarian on June 12, 2017. The APSS assistant asked to have the veterinarian call to update the case. On June 15, 2017 the regular veterinarian contacted the APSS to update the case. The regular veterinarian stated that the dog was taken in on June 12, 2017. The regular veterinarian stated there was serum exudate just cranial to the application site. The regular veterinarian soaked and shaved the area, started the dog on antibiotics, and provided symptomatic care (topical cream and apoquel). The APSS veterinarian recommended the regular veterinarian call back if symptomatic and supportive care does not make a big difference.