Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-7278
2. Registrant Information.
Registrant Reference Number: 130131843
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.
19-SEP-13
5. Location of incident.
Country: CANADA
Prov / State: UNKNOWN
6. Date incident was first observed.
19-SEP-13
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. 19209
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Flea and Tick Shampoo
- Active Ingredient(s)
- 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).
Starting on September 5, 2013 and continuing inappropriately every few days for about a week the owner bathed the dog with the shampoo product; the owner placed a flea and/or tick collar on the dog on September 15, 2013, and on September 18, 2013 the owner once again inappropriately bathed the dog with the shampoo product.
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
Dog / Chien
3. Breed
Parson Russell Terrier Mix
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
5.0
7. Weight (provide a range if necessary )
45.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Nervous and Muscular Systems
- Reproductive System
- Symptom - Other
- Specify - Swollen Genitalia
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 September 19, 2013 the owner noticed that the dog was symptomatic. Later that morning the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS assistant recommended that the owner bathe the dog with a liquid dish washing detergent (LDWD), take the dog to the veterinarian, have the veterinarian call for information, and call back with questions.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
The APSS veterinarian stated that the product was considered to have a doubtful likelihood of causing the clinical situation. An attempt to update the case was unsuccessful; therefore, the outcome is unknown. Extra Label Use: owner did not allow appropriate time between bathing dog with the product.