Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-7270
2. Registrant Information.
Registrant Reference Number: 130127234
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.
10-SEP-13
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
06-SEP-13
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. 26494
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
PMRA Registration No. 28743
PMRA Submission No.
EPA Registration No.
Product Name: Zodiac Spot On II 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 6, 2013 the owner applied the spot on product for dogs to the dog and the spot on product for cats to 3 cats. Unknown if owner consulted with veterinarian for spot on application to geriatric cat.
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
Dog / Chien
3. Breed
Miniature Pinscher
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
2.5
7. Weight (provide a range if necessary )
8.0
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 <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Lameness
- Symptom - Head shaking
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 6, 2013 the owner noticed that the dog was symptomatic. On September 9, 2013 the owner bathed the dog. On September 10, 2013 the owner took the dog to the veterinarian, where Prednisolone was given. Later that morning the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS assistant recommended that the owner monitor the dog at home, apply vitamin E, call back with questions, and have her regular veterinarian call for information if there were any questions regarding treatment.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Signs were expected to be mild and self-limiting.
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
Female
6. Age (provide a range if necessary )
2.0
7. Weight (provide a range if necessary )
8.5
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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
On September 6, 2013 the owner noticed that the cat was lethargic. On September 8, 2013 the owner noticed that the cat had fully recovered. On September 10, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated Methoprene is very safe, and that lethargy is a non-specific sign. The APSS assistant recommended that the owner 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.
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 )
1.5
7. Weight (provide a range if necessary )
10.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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
On September 6, 2013 the owner noticed that the cat was lethargic. On September 8, 2013 the owner noticed that the cat had fully recovered. On September 10, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated Methoprene is very safe, and that lethargy is a non-specific sign. The APSS assistant recommended that the owner 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.
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
Female
6. Age (provide a range if necessary )
17.0
7. Weight (provide a range if necessary )
9.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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
On September 6, 2013 the owner noticed that the cat was lethargic. On September 8, 2013 the owner noticed that the cat had fully recovered. On September 10, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated Methoprene is very safe, and that lethargy is a non-specific sign. The APSS assistant recommended that the owner 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 are expected to be mild and self limiting. Unknown if owner consulted with veterinarian before use on geriatric cat.