Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-6182
2. Registrant Information.
Registrant Reference Number: 140103173
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.
15-AUG-14
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
15-AUG-14
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. 28743
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Spot On II Flea Control for Cats and Kittens
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 August 15, 2014 the owner inappropriately applied the product onto the under labelled aged kitten, not realizing at the time that it was labeled for kittens that are older than 12 weeks old.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
No
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
Male
6. Age (provide a range if necessary )
0.17
7. Weight (provide a range if necessary )
2.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
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 August 15, 2014 the owner noticed the kitten was lethargic. Later that evening, the owner contacted the Animal Product Safety Service (APSS). The APSS technician recommended bathing the kitten (wash with liquid dish washing detergent (LDWD) and rinse well), consult with a veterinarian (to inquire about appropriate flea treatments for kittens of his age), and call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
Signs were expected to be mild and self-limiting. Extra Label Use: this product used on under labelled aged kitten.