Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-0185
2. Registrant Information.
Registrant Reference Number: 160044132
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.
30-MAR-16
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
30-MAR-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. 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 March 30, 2016 the owner applied the product onto the cat.
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
Abyssinian
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
3.0
7. Weight (provide a range if necessary )
3.46
kg
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
<=15 min / <=15 min
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
12. How long did the symptoms last?
<=30 min / <=30 min
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
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 March 30, 2016 the cat developed hypersalivation, so the owner gave the cat a bath (bathed off with hand soap). A little while later, the owner called the Animal Product Safety Service (APSS) and stated the cat did lick herself after application. The APSS assistant stated s-methoprene is an insect growth regulator (IGR) and primary concerns from topical administration are if ingested there could be hypersalivation and nausea. During the case, the cat's hypersalivation ended. The APSS assistant recommended monitoring the cat for gastrointestinal signs (if more than mild call back), manage vomiting (nothing by mouth (NPO) for 45 minutes, then give food and water), provide dilution (wet cat food or tuna juice to dilute), calling the veterinarian (to see what product to use on the pet since she washed it off), and calling 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.