Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2010-0235
2. Registrant Information.
Registrant Reference Number: 090111812
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.
05-OCT-09
5. Location of incident.
Country: CANADA
Prov / State: NOVA SCOTIA
6. Date incident was first observed.
25-SEP-09
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. 26496
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Spot On Flea Control for Cats and Kittens
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 September 14, 2009 the owner treated both geriatric cats with this product. It is unclear if a veterinarian was consulted before treatment on the aged pets.
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
Cat / Chat
3. Breed
Domestic Longhair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
15
7. Weight (provide a range if necessary )
11
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
- General
- Symptom -
- Specify - Decreased Grooming
12. How long did the symptoms last?
Persisted until death
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
Euthanised / Euthanasie
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 dermal reactions are possible and are mild, do not cause systemic illness, and are self limiting.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
It is unknown if a veterinarian was consulted before the elderly cats were treated.
Subform 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
Male
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
4.3
kg
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
- Gastrointestinal System
- Symptom - Mouth Irritation
- Specify - Oral Ulcers
- Symptom - Drooling
12. How long did the symptoms last?
Unknown / Inconnu
13. Was medical treatment provided? Provide details in question 17.
Yes
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 25, 2009 the cat received clindamycin hydrochloride and symptomatic care from the regular veterinarian. The APSS veterinarian stated that dermal reactions are possible and are mild, do not cause systemic illness, and are self limiting. The APSS veterinarian recommended tolfedine and symptomatic and supportive care.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
it is unknown if a veterinarian was consulted before the product was used on the aged cat.