Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2017-6998
2. Registrant Information.
Registrant Reference Number: 170171546
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.
02-OCT-17
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
01-OCT-17
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. 31982
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac InfeStop Topical Solution For Dogs 4.5 kg And Under
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.4
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 October 1, 2017 the owner applied the product to the dog as 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
Yorkshire Terrier
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.33
7. Weight (provide a range if necessary )
6.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Symptom - Other
- Specify - Application Site Mucopurlent Discharge
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
Thirty minutes after the product was applied on October 1, 2017 the dog developed pruritus. On October 2, 2017 the owner contacted the Animal Product Safety Service (APSS). While on call with the APSS, the owner observed pus at the application site. The APSS veterinarian stated that imidacloprid is an insecticidal agent that has a wide margin of safety in mammals and that it kills insects by binding to the nicotinic acetylcholine receptors in the insect nervous tissue. The APSS veterinarian also stated that the risks are for mild dermal irritation, sometimes from the carriers rather than imidacloprid itself. The APSS technician recommended the owner monitor for dermatological signs, bathe the dog (with liquid dish washing detergent (LDWD)), provide flea treatment (use another product once the itching has stopped), take the dog to a veterinarian, have the veterinarian call for information, and to call 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.