Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-4408
2. Registrant Information.
Registrant Reference Number: 130074072
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-JUN-13
5. Location of incident.
Country: UNITED STATES
Prov / State: WISCONSIN
6. Date incident was first observed.
28-MAY-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.
PMRA Submission No.
EPA Registration No. 2724-497-270
Product Name: Bio Spot Spot On Flea and Tick Control For Medium Size Dogs 31 - 60 lb
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3 %
- PERMETHRIN
- Guarantee/concentration 45 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
2
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 May 28, 2013 the owner applied 0.068 ounces (oz) of the product to the nursing mother dog and 3 of her puppies were exposed to the product via relay.
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
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Golden Retriever
4. Number of animals affected
2
5. Sex
Unknown
6. Age (provide a range if necessary )
0.10
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Unknown
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
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
Died
16. How was the animal exposed?
Contact treat.area/Contact surf. traitée
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On May 28, 2013 the owner noticed that the 2 puppies were symptomatic. On May 30, 2013 the 2 puppies died. On June 4, 2013 the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that if a puppy had managed to ingest a small amount of the product that had migrated to the mammary area of the mother dog, there might have been a mild bad taste reaction; the signs noted in these patients would not be expected.
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 not considered to be related to causing the clinical situation. A necropsy was not available for the 2 puppies. Unknown if veterinarian was consulted as per label before use on nursing dog.
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Golden Retriever
4. Number of animals affected
1
5. Sex
Unknown
6. Age (provide a range if necessary )
0.10
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Unknown
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Nervous and Muscular Systems
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
Died
16. How was the animal exposed?
Contact treat.area/Contact surf. traitée
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On May 28, 2013 the owner noticed that the puppy was symptomatic. On May 31, 2013 the puppy died. On June 4, 2013 the owner's regular veterinarian contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that if a puppy had managed to ingest a small amount of the product that had migrated to the mammary area of the mother dog, there might have been a mild bad taste reaction; the signs noted in this patient would not be expected.
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 not considered to be related to causing the clinical situation. A necropsy was not available for the puppy.