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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0131

2. Registrant Information.

Registrant Reference Number: 160051640

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.

13-APR-16

5. Location of incident.

Country: CANADA

Prov / State: NEWFOUNDLAND

6. Date incident was first observed.

07-APR-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 And Flea And Tick Control For Dogs

  • 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 April 7, 2016 the owner applied the product onto 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

Miniature Poodle Mix

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

31.0

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

  • Nervous and Muscular Systems
    • Symptom - Restlessness
    • Symptom - Agitation
  • General
    • Symptom - Weakness

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

13. Was medical treatment provided? Provide details in question 17.

No

14. a) Was the animal hospitalized?

No

14. b) How long was the animal hospitalized?

15. Outcome of the incident

Fully Recovered / Complètement 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 April 7, 2015 the dog developed symptoms. On April 13, 2016 the owner called the Animal Product Safety Service (APSS). The APSS veterinarian stated that permethrins 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, and may experience rolling, hiding, vocalization, clingy behavior, lethargy, panting, reluctance to move, or have an abnormal gait (ex. take a few steps, stop, sit down and turn quickly toward their tail). 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 stated furthermore s-methoprene is an insect growth regulator (IGR). The APSS veterinarian finally stated primary concerns from topical administration are for mild dermal irritation and redness, usually from the carriers. The APSS technician relayed that the APSS veterinarian stated it was possible the dog was sensitive to the product, but she wouldn't expect the signs to have lasted that long though. She also relayed that the dog could possibly have an underlying condition we are not aware of that was affected with this product. The APSS technician recommended preventing further exposure (not using this product again) and consulting with a veterinarian (on what type of product to use). The owner stated she had used the product in the past (only in the summer time). The APSS technician relayed another APSS veterinarian's thoughts as the dog could have a sensitivity from having such a long break since the last time it was used. She also stated wouldn't expect the signs to have lasted this long and if the owner gave the dog a bath right before using the product, it could potentially have caused the symptoms to last longer.


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 substance was not considered to be related to causing the clinical situation. On April 19, 2016 the owner returned the APSS's follow-up call. The owner stated the dog's weakness ended on April 13, 2016 and the dog's restlessness and agitation ended on April 15th, 2016. The owner stated the dog was not taken to the veterinarian and the dog fully recovered.