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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0042

2. Registrant Information.

Registrant Reference Number: 150100475

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.

24-JUL-15

5. Location of incident.

Country: CANADA

Prov / State: NOVA SCOTIA

6. Date incident was first observed.

23-JUL-15

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. 26494      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

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

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 July 23, 2015 the owner applied the products onto the dogs 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

Chihuahua

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

2.5

7. Weight (provide a range if necessary )

7.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
  • General
    • Symptom - Abnormal behaviour
    • Specify - Kicking
  • Skin
    • Symptom - Hair loss
  • General
    • Symptom - Abnormal behaviour
    • Specify - Rolling

12. How long did the symptoms last?

Unknown / Inconnu

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

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 July 23, 2015 the dog developed pruritus and started kicking and rolling. On July 24, 2015 the dog developed alopecia. A few hours later the owner bathed the dog with pet soap, then an hour later with Dawn. Later that afternoon, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dogs tolerate pyrethroids well and no life threatening signs are expected. The APSS veterinarian also stated pyrethroids can cause a "pins and needles" sensation or hyperesthesia, resulting in reluctance to move, mild tremors, paw shaking, ear twitching or facial fasciculations. The APSS veterinarian further stated that some dogs will develop erythema and pruritus as well. The APSS assistant recommended monitoring the dog at home, applying a cold compress, applying vitamin E, monitoring for dermatological signs, 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

Signs were expected to be mild and self-limiting.

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

Pembroke Welsh Corgi Mix

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

3.0

7. Weight (provide a range if necessary )

36.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

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

10. Time between exposure and onset of symptoms

<=30 min / <=30 min

11. List all symptoms

System

  • Skin
    • Symptom - Pruritus
    • Symptom - Hair loss
  • General
    • Symptom - Abnormal behaviour
    • Specify - Rolling

12. How long did the symptoms last?

Unknown / Inconnu

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

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 July 23, 2015 the dog developed pruritus and later that evening started rolling. On July 24, 2015 the dog developed alopecia. A few hours later the owner bathed the dog with pet soap, then an hour later with Dawn. Later that afternoon, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated dogs tolerate pyrethroids well and no life threatening signs are expected. The APSS veterinarian also stated pyrethroids can cause a "pins and needles" sensation or hyperesthesia, resulting in reluctance to move, mild tremors, paw shaking, ear twitching or facial fasciculations. The APSS veterinarian further stated that some dogs will develop erythema and pruritus as well. The APSS assistant recommended monitoring the dog at home, applying a cold compress, applying vitamin E, monitoring for dermatological signs, 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

Signs were expected to be mild and self-limiting.