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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0156

2. Registrant Information.

Registrant Reference Number: 160131601

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-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ALBERTA

6. Date incident was first observed.

03-SEP-16

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. 31366      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerspot with Smart Shield F&T Control for Dogs Over 14kg

  • 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 2, 2016 the owner applied the product to the dog 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

Medical Professional

2. Type of animal affected

Dog / Chien

3. Breed

Alaskan Husky

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.66

7. Weight (provide a range if necessary )

55.6

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

  • Gastrointestinal System
    • Symptom - Vomiting
  • Renal System
    • Symptom - Blood in urine
    • Specify - Hematuria

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

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 September 3, 2016 the dog developed symptoms. Later that morning, the owner took the dog to the veterinarian. Shortly after, the attending veterinarian called the Animal Product Safety Service (APSS). The attending veterinarian described the hematuria as brick red urine. The APSS veterinarian stated if ingested, could see some nausea/gastrointestinal (GI) upset. The APSS veterinarian finally stated she would not expect to see hematuria or any other urinary tract signs. The APSS veterinarian recommended obtaining additional information (have owner's go home to find label, confirm PCPA, maybe find lot number), a diagnostic evaluation (urinalysis to assess hematuria vs hemoglobinuria; look for evidence of cystitis), and calling 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 cystitis was suspected. On September 6, 2016 an APSS assistant called the attending veterinary clinic to follow up on the case. The attending veterinary staff stated that they had spoken with the owner on September 4, 2016 and the dog's vomiting had ended that day and the dog's hematuria had become mild. The attending veterinary staff stated that overall the dog had improved and was doing well. On September 7, 2016 the APSS received the dog's medical record, which confirmed the product involved with the lot number.