Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-2749

2. Registrant Information.

Registrant Reference Number: 150051149

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.

21-APR-15

5. Location of incident.

Country: CANADA

Prov / State: ONTARIO

6. Date incident was first observed.

14-APR-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. 19210      PMRA Submission No.       EPA Registration No.

Product Name: Zodiac Breakaway Flea and Tick Collar For Cats

• Active Ingredient(s)
  • 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 April 12, 2015 the owner put the collar onto the cat for prevention, trimming the excess.

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

Siamese

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

0.31

7. Weight (provide a range if necessary )

2.0

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

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

11. List all symptoms

System

• Skin
  • Symptom - Pruritus

• Gastrointestinal System
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Limp

• Cardiovascular System
  • Symptom - Bradycardia

• General
  • Symptom - Dehydration

• Gastrointestinal System
  • Symptom - Anorexia

• Blood
  • Symptom - Blood urea nitrogen increased
  • Specify - Azotemia
  • Symptom - Hypokalemia

• General
  • Symptom - Hypothermia

12. How long did the symptoms last?

Unknown / Inconnu

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

Yes

14. a) Was the animal hospitalized?

Yes

14. b) How long was the animal hospitalized?

Unknown

15. Outcome of the incident

Not recovered / Non 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 14, 2015 the cat developed pruritus. On April 15, 2015 the owner removed the collar. On April 16, 2015 the cat started vomiting. On April 18, 2015 the cat became lethargic and anorexic. On April 19, 2015 the owner woke up with the cat next to her and when she picked her up the cat was limp (eyes open), so the owner gave the cat some water and then took the cat to the veterinarian where the cat's lethargy became severe, so the cat was hospitalized for treatment. On April 21, 2015 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian recommended having the veterinarian call for information since signs are far more significant than what we would expect from this agent. Shortly after, the attending veterinarian called the APSS and stated that on April 19, 2015 the cat was diagnosed with bradycardia, dehydration, azotemia, hyperkalemia, and hypothermia. The attending veterinarian performed some laboratory tests, put the cat on fluid therapy, provided thermoregulation and nutritional support (force feeding a/d). On April 21, 2015 the attending veterinarian gave the cat lactulose and the cat's hypothermia became mild. The APSS veterinarian stated propoxur is a carbamate insecticide that is often used in flea collars for dogs and cats, and when used per label it has a wide margin of safety. The APSS veterinarian also stated that if the collars are chewed or ingested, signs of hypersalivation, vomiting, possibly diarrhea, and ataxia may occur but are usually transient. The APSS veterinarian further stated some animals may have pruritus from the collar, or behavioral changes if they are not used to wearing collars, but severe signs are not expected. The APSS veterinarian recommended continuing treatment and providing symptomatic and supportive care.

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To be determined by Registrant

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

Major

19. Provide supplemental information here

The APSS veterinarian stated that the substance was not considered to be related to causing the clinical situation.