Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0139

2. Registrant Information.

Registrant Reference Number: 160108289

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-16

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

23-JUL-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)

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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

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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 21, 2016 the owner applied the product onto the dog for 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

Female

6. Age (provide a range if necessary )

6.0

7. Weight (provide a range if necessary )

9.5

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

• Gastrointestinal System
  • Symptom - Other
  • Specify - Decreased Defecation
  • Symptom - Anorexia

• General
  • Symptom - Lethargy

• Gastrointestinal System
  • Symptom - Other
  • Specify - Decrease in Amount of Feces

• General
  • Symptom - Other
  • Specify - Tenesmus
  • Symptom - Licking

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 July 23, 2016 the dog developed symptoms. On July 24, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian 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. The APSS veterinarian stated furthermore oral exposures can lead to hypersalivation, vomiting, and diarrhea. The APSS veterinarian stated in addition s-methoprene is an insect growth regulator (IGR). The APSS veterinarian finally stated primary concerns from topical administration are if ingested there could be hypersalivation and nausea. The APSS assistant stated that per the APSS veterinarian we would not expect constipation issues with the product and recommended monitoring the dog at home (if the dog stays the same and does not worsen then can call veterinarian tomorrow). The APSS assistant also recommended taking the dog to the veterinarian and having the veterinarian call for information (if the dog worsens or any bloody stools develop today).

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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 July 24, 2016 the owner called the APSS back to inquire if there was anything he could give to his dog for constipation. The APSS technician stated that per the APSS veterinarian there is nothing we can recommend over the phone. The APSS technician again recommended the owner contact his local veterinarian. On July 26, 2016 the owner called the APSS back and stated the dog had developed licking that day (either her vulva or perineal region). The owner stated the dog was eating a little more and drinking normal amounts of water. The owner also stated he has had the dog for 2 years and has not taken her to the veterinarian. The APSS veterinarian recommended taking the dog to the veterinarian for a check up. The APSS veterinarian stated the licking could be a skin infection or anal gland problem. A follow up was not performed, because no significant signs were expected.