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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-0228
2. Registrant Information.
Registrant Reference Number: 090098228
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.
31-AUG-095. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
29-AUG-09Product 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. 26496 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Spot On Flea Control for Cats and Kittens
- Active Ingredient(s)
- (S)-METHOPRENE
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1Units: 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 August 20, 2009 the pet owner applied the product to her cats to treat a flea infestation.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
5
7. Weight (provide a range if necessary )
10
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
- Skin
- Symptom - Hyperesthesia
- General
- Symptom - Hiding
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
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
Fully Recovered / Complètement rétabli
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
The APSS veterinarian stated that, due to the timing of the onset of symptoms, the product was not likely causing the signs the cat was experiencing and discussed the possibility that the cat was experiencing a flea allergy dermatitis. The APSS veterinarian recommended that the pet owner take the cat to the veterinarian and have the veterinarian call for information if needed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 4, 2009 an APSS assistant spoke to the pet owner. The pet owner stated that she did not seek veterinary care, and the cat made a full recovery on September 3, 2009.
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cat / Chat
3. Breed
Domestic Longhair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
3
7. Weight (provide a range if necessary )
10
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
- Skin
- Symptom - Erythema
- General
- Symptom - Pain
12. How long did the symptoms last?
Unknown / Inconnu
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
Not recovered / Non rétabli
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
The APSS veterinarian stated that, due to the timing of the onset of symptoms, the product was not likely causing the signs the cat was experiencing and discussed the possibility that the cat was experiencing a flea allergy dermatitis. The APSS veterinarian recommended that the pet owner take the cat to the veterinarian and have the veterinarian call for information if needed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Minor
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. On September 4, 2009 an APSS assistant spoke to the pet owner. The pet owner stated that she did not seek veterinary care for the cat. The erythema persisted, and the product application site had become painful so she was applying an antibiotic ointment. The APSS veterinarian recommended that the pet owner take the cat to the veterinarian and have the veterinarian call for information if needed.
