Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-0151
2. Registrant Information.
Registrant Reference Number: 100095499
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.
23-JUL-10
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
23-JUL-10
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 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 July 23, 2010 the owner sprayed the product onto the dog.
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
Canine Domestic Unspecified Mix
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
0.75
7. Weight (provide a range if necessary )
15
lbs
8. Route(s) of exposure
Skin
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
- Skin
- Symptom - Discolouration
- Specify - skin turned a fluorescent lilac color
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 July 23, 2010 the dog's skin turned a fluorescent lilac color almost immediately after the product was applied. The owner then bathed the dog with shampoo and the skin returned to normal color. Shortly after, the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated use of flea and tick sprays per label directions is not expected to cause significant clinical signs and the concentration of active ingredients is typically quite low, so even ingestion of the agent via licking does not pose a significant threat of toxicity. The APSS veterinarian also stated the skin/coat turning a fluorescent lilac color immediately after product application is not expected with this agent. The APSS veterinarian stated no treatment was necessary. She recommended verifying what is actually in the bottle, and if it had been reused, discontinuing product usage, 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.