Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2011-3864
2. Registrant Information.
Registrant Reference Number: 110078356
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.
22-JUN-11
5. Location of incident.
Country: UNITED STATES
Prov / State: NORTH CAROLINA
6. Date incident was first observed.
20-JUN-11
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. 2724-796-270
Product Name: Adams Flea And Tick Spot On E30 For Extra Large Dogs 81 Lbs And Over
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3.6 %
- ETOFENPROX
- Guarantee/concentration 30 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 5 %
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
9
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 June 20, 2011 the owner applied the product to the dog.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Labrador Retriever
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
1.58
7. Weight (provide a range if necessary )
90.0
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Bloody vomit
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 the evening of June 20, 2011 the owner noticed the dog was symptomatic. The next morning, on June 21, 2011, the owner found the dog had died. On June 22, 2011 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian further stated that death would not be expected with 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. On June 26, 2011, an APSS technician asked an APSS veterinarian to call the owner to discuss the case. Later that day, an APSS veterinarian called the owner and explained that a necropsy was not possible, as the dog's body had been buried and was not in suitable condition for a necropsy.