Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2016-5175
2. Registrant Information.
Registrant Reference Number: 160095353
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.
01-JUL-16
5. Location of incident.
Country: UNITED STATES
Prov / State: NEW JERSEY
6. Date incident was first observed.
25-JUN-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.
PMRA Submission No.
EPA Registration No. 2724-813-89459
Product Name: Bio Spot Active Care F&T Spot On For Cats Smart Shield 5 lbs And Over
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3.6 %
- ETOFENPROX
- Guarantee/concentration 40 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
1.8
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 June 24, 2016 the owner applied the product, for the first time, onto the cat to treat for 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 )
8.0
7. Weight (provide a range if necessary )
8.0
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
- Nervous and Muscular Systems
- Gastrointestinal System
- Symptom - Loss of appetite
12. How long did the symptoms last?
Persisted until death
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
Died
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 June 25, 2016, the cat developed pale ataxia. On June 26, 2016 the cat developed inappetence, lethargy, and anorexia. The owner wiped off the cat's coat/skin (Dove soap on a cloth, not a full bath - wiped the application site) on June 27, 2016. On June 30, 2016 the cat passed away. On July 01, 2016, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the ingredients in this agent have a good margin of safety in cats. The APSS veterinarian also stated you can see mild tremors as an adverse reaction. The APSS veterinarian finally stated serious systemic effects are not expected; would not expect this clinical picture. The APSS veterinarian recommended a necropsy but the cat was buried yesterday and the outdoor termperature is in the mid eighties so a necropsy was unavailable.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation.