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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-5653
2. Registrant Information.
Registrant Reference Number: 110084443
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.
04-JUL-115. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
04-JUL-11Product 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. 28743 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Spot On II 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 July 4, 2011 the owner applied the product to 2 kittens and 1 adult cat.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
Cat / Chat
3. Breed
American Shorthair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
0.15
7. Weight (provide a range if necessary )
2.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
<=15 min / <=15 min
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Drooling
- General
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
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
Died
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 July 4, 2011, just after the product was applied, the kitten began drooling, and then died a few minutes later. Shortly after the kitten died, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk was for a taste reaction if the product was ingested.The APSS veterinarian continued by stating that some cats may also react to the scent of the product with drooling. The APSS veterinarian stated that death was not expected from the use of the product.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A necropsy was not available because multiple attempts to contact the owner were unsuccessful. The product was not used according to label directions as the cat was under 12 weeks of age.
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 )
0.19
7. Weight (provide a range if necessary )
4.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
<=15 min / <=15 min
10. Time between exposure and onset of symptoms
<=30 min / <=30 min
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Drooling
- General
- Symptom - Death
12. How long did the symptoms last?
Persisted until death
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
Died
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 July 4, 2011, just after the product was applied, the kitten began drooling, and then died a few minutes later. Shortly after the kitten died, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk was for a taste reaction if the product was ingested. The APSS veterinarian continued by stating that some cats may also react to the scent of the product with drooling. The APSS veterinarian stated that death was not expected from the use of the product.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
The APSS veterinarian stated that the substance was considered to have a doubtful likelihood of causing the clinical situation. A necropsy was not available because multiple attempts to contact the owner were unsuccessful. The product was not used according to label directions as the cat was under 12 weeks of age.
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
Female
6. Age (provide a range if necessary )
2.0
7. Weight (provide a range if necessary )
7.0
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
- Gastrointestinal System
- Symptom - Drooling
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
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 July 4, 2011, just after the product was applied, the cat began drooling. Shortly after applying the product, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk was for a taste reaction if the product was ingested. The APSS veterinarian continued by stating that some cats may also react to the scent of the product with drooling. The APSS veterinarian recommended that the owner bathe the cat with liquid dish washing detergent (LDWD), provide a taste treat, monitor the cat at home, and 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 expected to be mild and self limiting.
