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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2014-0791
2. Registrant Information.
Registrant Reference Number: 130138787
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.
03-OCT-135. Location of incident.
Country: UNITED STATES
Prov / State: WEST VIRGINIA
6. Date incident was first observed.
Unknown
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. 2724-811-270
Product Name: Bio Spot Defense Flea And Tick Spot On For Small Dogs 13 to 31 lbs
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration 3.6 %
- ETOFENPROX
- Guarantee/concentration 30 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 5 %
- (S)-METHOPRENE
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
1.5Units: 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).
Starting on January 2, 2013 and continuing once every three months until October 2, 2013 the owner inappropriately applied 1.5 milliliters (mL) of the product to the dog.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
Miniature Dachshund
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
13.0
7. Weight (provide a range if necessary )
22.5
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>6 mos <=1 yr / > 6 mois < = 1 an
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Polydipsia
- Gastrointestinal System
- Symptom - Retching
- Nervous and Muscular Systems
- Symptom - Abnormal posture
- Gastrointestinal System
- Symptom - Abdominal distension
- 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 an unknown date, the owner noticed that the dog had polydipsia. On October 2, 2013, several hours after the owner gave the dog a half dose of the product, the owner noticed that the dog was retching and had an abnormal posture, as though he were trying to have a bowel movement. A short time later the owner noticed that the dog had an abdominal distension. The owner took the dog to the veterinarian that evening, but the dog died before arrival at the clinic. On October 3, 2013 the owner contacted the Animal Product Safety Service (APSS) to obtain help. A necropsy was not available.
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 and that gastric dilitation and volvulus was considered to have a medium likelihood of causing the clinical situation. Extra Label Use: owner inappropriately split dosage.
