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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0145

2. Registrant Information.

Registrant Reference Number: 160142024

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.

22-SEP-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

17-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. 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

PMRA Registration No. 21744      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Flea and Tick Spray for Dogs and Cats

  • Active Ingredient(s)
    • (S)-METHOPRENE
    • N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
    • PIPERONYL BUTOXIDE
    • 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).

On August 1, 2016 the dog had a flea infestation and pruritus. On August 5, 2016 the owner applied an unknown flea and tick collar onto the dog. On September 2, 2016 the owner took the dog to the veterinarian, started using an Elizabethan collar, and used a flea comb. At the beginning of September, the regular veterinarian gave the owner a medicated shampoo which was used on September 4, 2016 and again on September 16, 2016. On September 4, 2016 the owner applied the Zodiac Flea and Tick Spray. On September 8, 2016 the owner applied flea and tick drops. On September 18, 2016 the owner inappropriately applied the Zodiac Powerspot Flea and Tick Control.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

West Highland White Terrier

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

9.5

7. Weight (provide a range if necessary )

20.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • Skin
    • Symptom - Hair loss
    • Symptom - Erythema

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 September 17, 2016 the dog developed alopecia and erythema. On September 21, 2016 the dog's alopecia worsened. On September 22, 2016 the owner called the Animal Product Safety Service (APSS). The APSS veterinarian stated with the Zodiac Powerspot, the flea and tick drops, and the Zodiac Flea and Tick Spray, permethrins and pyrethroids can cause a tingling sensation to the skin, as well as redness, dermal irritation, and pruritus. The APSS veterinarian also stated occasionally animals will develop sores or scabs, and alopecia secondary to scratching or biting the application site. The APSS veterinarian additionally stated some animals are more sensitive to the ingredients than others. The APSS veterinarian further stated signs often resolve after bathing and with topical applications of vitamin E and cool compresses, but may take up to 24-72 hours. The APSS veterinarian finally stated s-methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. The APSS veterinarian stated with the flea and tick collar mild dermatitis, mild agitation are possible. The APSS veterinarian stated with the medicated shampoo significant clinical signs are not expected. The APSS assistant advised the owner per the APSS veterinarian that the symptoms seem to indicate flea allergy dermatitis rather than any reaction to the products used. The APSS assistant also relayed that the topical spot on products can cause alopecia in some pets, but that is usually limited to the application site. The APSS assistant recommended bathing the dog (with liquid dish washing detergent (LDWD)) to remove the product as a precaution, taking the dog to the veterinarian (to discuss other flea preventives that would be more effective), have the veterinarian call for information, 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 the Zodiac Powerspot, the flea and tick drops, the flea and tick collar, the medicated shampoo, and the Zodiac Flea and Tick Spray were not considered to be related to causing the clinical situation. Flea allergy dermatitis suspected. Incorrect dosage applied to the dog.