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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0125

2. Registrant Information.

Registrant Reference Number: 160061807

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.

02-MAY-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

01-MAY-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. 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

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 April 30, 2016 the owner applied the product onto both 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 )

2.0

7. Weight (provide a range if necessary )

6.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Head shaking
  • Skin
    • Symptom - Pruritus
  • Gastrointestinal System
    • Symptom - Vomiting

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 May 1, 2016 the dog developed lethargy, head shaking, and pruritus. On May 2, 2016 the dog developed vomiting, so the owner bathed the dog (Hartz dog shampoo) and then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the ingredients in this agent have a good margin of safety in dogs. The APSS veterinarian also stated dermal and dermal paresthesia reactions in sensitive individuals can be seen. The APSS veterinarian finally stated those signs are usually limited to the area near the application site. The APSS technician recommended bathing the dog (re-bathe with liquid dish washing detergent (LDWD) like Dawn), monitoring for dermatological signs, taking the dog to the veterinarian, 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 substance was considered to have a doubtful likelihood of causing the clinical situation. 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

Chihuahua

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

8.0

7. Weight (provide a range if necessary )

5.0

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Lethargy
  • Nervous and Muscular Systems
    • Symptom - Head shaking
  • Skin
    • Symptom - Pruritus

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 May 1, 2016 the dog developed symptoms. On May 2, 2016 the owner bathed the dog and then contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the ingredients in this agent have a good margin of safety in dogs. The APSS veterinarian also stated dermal and dermal paresthesia reactions in sensitive individuals can be seen. The APSS veterinarian finally stated those signs are usually limited to the area near the application site. The APSS technician recommended bathing the dog, monitoring for dermatological signs, taking the dog to the veterinarian, 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 substance was considered to have a doubtful likelihood of causing the clinical situation. No significant signs were expected.