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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-0128
2. Registrant Information.
Registrant Reference Number: 120098084
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.
16-JUL-125. Location of incident.
Country: CANADA
Prov / State: BRITISH COLUMBIA
6. Date incident was first observed.
15-JUL-12Product 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. 19210 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Breakaway Flea and Tick Collar For Cats
- Active Ingredient(s)
- PROPOXUR
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1Other Units: count
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 15, 2012 the owner placed a flea and tick collar on her two cats.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Other
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
2.0
7. Weight (provide a range if necessary )
7.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Trembling
- Gastrointestinal System
- Symptom - Drooling
- Nervous and Muscular Systems
- Symptom - Ataxia
- Specify - Rear Limb Ataxia
12. How long did the symptoms last?
>30 min <=2 hrs / >30 min <=2 h
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
Fully Recovered / Complètement 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 July 15, 2012 the owner noticed that the cat was trembling, drooling, and experiencing hind limb ataxia. A short time after noticing the cat's signs, the owner removed the flea and tick collar. Later that evening, the owner observed that the cat had fully recovered. On July 16, 2012 an employee of the store where the owner purchased the flea and tick collar contacted the Animal Product Safety Service (APSS) to obtain help. The owner was also in the store to provide information to the APSS. The APSS veterinarian stated that the collar as formulated has a wide margin of safety in cats and that drooling can be seen when some of the powder from the collar is ingested. The APSS veterinarian also stated that some cats will show a behavior change when collars are applied and tremble when they are upset; true ataxia is uncommon following the application of this type of collar. The APSS veterinarian referred the owner to the product's manufacturer to discuss concerns about the formulation of the collar and recommended that the owner call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.
Subform III: Domestic Animal Incident Report
1. Source of Report
Other
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 )
4.0
7. Weight (provide a range if necessary )
15.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- General
- Symptom - Abnormal behaviour
- Specify - Behavior Change
- Nervous and Muscular Systems
- Symptom - Ataxia
- Specify - Hind Limb Ataxia
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
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 July 15, 2012 the owner noticed that the cat had a behavior change, hissing and growling at another cat who lived in the house, and was experiencing hind limb ataxia. A short time after noticing the cat's signs, the owner removed the flea and tick collar. Later that evening, the owner observed that the cat's behavior toward the other cat had improved somewhat. On July 16, 2012 an employee of the store where the owner purchased the flea and tick collar contacted the Animal Product Safety Service (APSS) to obtain help. The owner was also in the store to provide information to the APSS. The APSS veterinarian stated that the collar as formulated has a wide margin of safety in cats and that drooling can be seen when some of the powder from the collar is ingested. The APSS veterinarian also stated that some cats will show a behavior change when collars are applied and tremble when they are upset; true ataxia is uncommon following the application of this type of collar. The APSS veterinarian referred the owner to the product's manufacturer to discuss concerns about the formulation of the collar and recommended that the owner call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a medium likelihood of causing the clinical situation. A follow up was not performed, because additional information was not expected.
