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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-7370

2. Registrant Information.

Registrant Reference Number: 161207-000068

Registrant Name (Full Legal Name no abbreviations): Rolf C Hagen Inc

Address: 20500 Trans Canada Hwy

City: Baie d'Urf

Prov / State: Qc

Country: Canada

Postal Code: H9X 0A2

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

07-DEC-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

15-NOV-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. 21629      PMRA Submission No.       EPA Registration No.

Product Name: Sergeant's Flea & Tick Spray for Dogs

  • Active Ingredient(s)
    • PERMETHRIN
    • PYRETHRINS

7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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).

The spray was appplied by starting from the tail base up to mid back/shoulder blades to treat an existing flea infestation.

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

Mixed Breed

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

10

7. Weight (provide a range if necessary )

25

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Symptom - Pruritus
    • Symptom - Dry skin
    • Symptom - Peeling skin

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

The day after the product was applied, the pet owner noticed bumps, flaking skin and hair loss on the pet's back, where the product was applied. The scratching increased. The pet was brought into a DMV on 11/15/2016 were it was diagnosed with a skin infection. The pet was prescribed antibiotics, medicated shampoo and Advantage II for flea treatment. The pet was rechecked on 11/29/2016 at the DVM. The skin was still peeling and the fur continued to fall.


To be determined by Registrant

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

Moderate

19. Provide supplemental information here