Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6928
2. Registrant Information.
Registrant Reference Number: 180150927
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.
06-SEP-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
06-SEP-18
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. 31368
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Spot On II With Smart Shield 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 September 6, 2018, the owner applied the product to the two cats to treat a condition.
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 Mediumhair
4. Number of animals affected
2
5. Sex
Female
6. Age (provide a range if necessary )
0.25
7. Weight (provide a range if necessary )
4.0
lbs
8. Route(s) of exposure
Skin
Oral
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 - Other
- Specify - Application Site Licking
- Nervous and Muscular Systems
- Skin
- Symptom - Pruritus
- Specify - Application Site Pruritus
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
Right after the product was applied, the cats developed symptoms. Soon after, the owner contacted the Animal Product Safety Service (APSS), whose technician stated that the risk is for dermal hypersensitivity and taste reaction/mild vomiting if ingested. The APSS technician recommended the owner monitor at home, monitor for dermatological signs (monitor for irritated skin), monitor for gastrointestinal signs (drooling, vomiting), provide a taste treat (offer a small amount of milk or tuna juice if they start to hypersalivate), and to call back with questions (or if signs become more than mild).
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here