Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-0136
2. Registrant Information.
Registrant Reference Number: 160070708
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.
18-MAY-16
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
16-MAY-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. 31367
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Powerspot With Smart Shield F&T For Dogs Under 14kg
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
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 May 16, 2016 the owner applied the product onto the dog for prevention.
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
Dog / Chien
3. Breed
Chihuahua Mix
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
3.5
7. Weight (provide a range if necessary )
10.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Head shaking
- Symptom - Fasciculations
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 May 16, 2016 the dog had an episode of fasciculation. On May 17, 2016 the dog developed fasciculation and later that afternoon developed head shaking. Later that day, the owner bathed the dog (Hartz Extra Gentle Shampoo) and shortly after gave another bath (Garnier Shampoo). On May 18, 2016 the owner contacted the Animal Product Safety Service (APSS). The APSS veterinarian stated the ingredients in this agent have a wide margin of safety in dogs. The APSS veterinarian also stated dermal and dermal paresthesia reactions in sensitive individuals can be seen and those signs are usually seen at the application site. The APSS veterinarian finally stated some dogs tremble when they are feeling uncomfortable. The APSS technician recommended bathing the dog (liquid dish washing detergent (LDWD)), applying a cold compress, taking the dog to the veterinarian (if signs continue), and having the veterinarian call for information.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
No significant signs were expected.