Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-0095

2. Registrant Information.

Registrant Reference Number: 150138330

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.

06-OCT-15

5. Location of incident.

Country: CANADA

Prov / State: QUEBEC

6. Date incident was first observed.

06-OCT-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)

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PMRA Registration No. 28199      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Powerband Plus Dual Action Flea and Tick Collar for Cats

• Active Ingredient(s)
  • (S)-METHOPRENE
  • PROPOXUR

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7. b) Type of formulation.

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 October 6, 2015 the owner put the collars onto the two kittens after seeing fleas.

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

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.42

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>30 min <=2 hrs / >30 min <=2 h

11. List all symptoms

System

• Nervous and Muscular Systems
  • Symptom - Ataxia

• General
  • Symptom - Licking

• Nervous and Muscular Systems
  • Symptom - Shaking
  • Specify - Paw Shaking
  • Symptom - Fasciculations

• General
  • Symptom - Pale mucous membrane colour

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 October 6, 2015 the kitten developed ataxia and started licking, so the owner removed the collar and rinsed the kitten's coat/skin (with water as owner doesn't have liquid dish washing detergent (LDWD) as she uses organic soap that has essential oils). A short time later the owner contacted the Animal Product Safety Service (APSS) and during the call the kitten developed paw shaking (laying on her side and the back leg was twitching, then would stop, then would twitch and stop) and fasciculation. While the owner was still speaking with the APSS the kitten developed pale mucous membrane color. The APSS veterinarian stated propoxur is a carbamate insecticide and carbamates can result in muscarinic salivation, lacrimation, urination, defecation, dyspnea, emesis (SLUDDE) signs as well as nicotinic signs (twitching/tremors) and seizures. The APSS veterinarian also stated significant systemic effects are not likely from exposure to the collar (even following ingestion). The APSS veterinarian finally stated hypersalivation (taste reaction) and mild gastrointestinal (GI) upset can occur from mouthing the collar. The APSS veterinarian recommended taking the kitten to the veterinarian (if kitten is no better in 30 minutes; initial visit for exam and deworming), having the veterinarian call for information, monitoring the kitten at home (since stable now), and rinsing the kitten's coat/skin (can use a wet wash cloth and wash around the neck again if unwilling to get a regular LDWD).

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.42

7. Weight (provide a range if necessary )

Unknown

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

• General
  • Symptom - Pale mucous membrane colour

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 October 6, 2015 the owner removed the collar and then contacted the Animal Product Safety Service (APSS); during the call the kitten became symptomatic. The APSS veterinarian stated propoxur is a carbamate insecticide and carbamates can result in muscarinic salivation, lacrimation, urination, defecation, dyspnea, emesis (SLUDDE) signs as well as nicotinic signs (twitching/tremors) and seizures. The APSS veterinarian also stated significant systemic effects are not likely from exposure to the collar (even following ingestion). The APSS veterinarian finally stated hypersalivation (taste reaction) and mild gastrointestinal (GI) upset can occur from mouthing the collar. The APSS veterinarian recommended taking the kitten to the veterinarian (initial visit for exam and deworming) and calling back with questions.

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To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Moderate

19. Provide supplemental information here