Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-6916
2. Registrant Information.
Registrant Reference Number: 180099332
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.
12-JUN-18
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
12-JUN-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. 21744
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Fleatrol Flea and Tick Spray For Dogs and Cats
- Active Ingredient(s)
- (S)-METHOPRENE
- N-OCTYL BICYCLOHEPTENE DICARBOXIMIDE
- PIPERONYL BUTOXIDE
- PYRETHRINS
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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 12, 2018 the owner applied the spray and rubbed it into the dog's belly to treat a condition.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Akita
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
10.0
7. Weight (provide a range if necessary )
110.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>15 min <=2 hrs / >15 min <=2 h
10. Time between exposure and onset of symptoms
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Nervous and Muscular Systems
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
Soon after the product was applied on June 12, 2018, the dog developed an abnormal gait (walking crookedly or like he had a hitch or pain in his hip). Half an hour later, the owner bathed the dog using Ivory body wash. After the bath, the dog's abnormal gait became more mild and he seemed to be doing better. Shortly after, the dog developed an eyelid edema but the owner stated he is unsure if this was due to the product or when the dog was brushed. The owner then contacted the Animal Product Safety Service (APSS). The APSS assistant recommended the owner monitor at home, bathe with dish washing liquid (DWL), monitor for dermatological signs (if fleas bite, that could cause some irritation), and to call back with questions. The owner then stated that he does not want to bathe the dog with DWL and that he has an appointment with his regular veterinarian later that day.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here