Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-2018
2. Registrant Information.
Registrant Reference Number: 110152283
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.
30-NOV-11
5. Location of incident.
Country: UNITED STATES
Prov / State: VIRGINIA
6. Date incident was first observed.
30-NOV-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 November 30, 2011 the owner applied the wrong dose of the product to the dog to treat for fleas.
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
Dog / Chien
3. Breed
Golden Retriever
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
12.0
7. Weight (provide a range if necessary )
78.0
lbs
8. Route(s) of exposure
Skin
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
- Renal System
- Symptom - Urinary incontinence
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 November 30, 2011 the owner noticed that the dog was symptomatic. Later that evening, the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS veterinarian stated that the risk was for a taste reaction or dermal irritation. The APSS veterinarian recommended that the owner take the dog to the veterinarian and have the veterinarian call for information.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
On December 8, 2011 the owner called the APSS to update the case. The owner stated that she bathed the dog on the evening of November 30, 2011 and that the dog's symptoms were milder on December 1, 2011. The owner also stated that on December 2, 2011 the dog became moderately lethargic, and on December 3, 2011 the dog died. A necropsy was not available because the dog's body was not available. No veterinary care was sought.