Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-3377
2. Registrant Information.
Registrant Reference Number: 080037793
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.
14-APR-08
5. Location of incident.
Country: UNITED STATES
Prov / State: PENNSYLVANIA
6. Date incident was first observed.
11-APR-08
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 Dogs 16 to 30 lbs
- 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.
.034
Units: oz (fl) / oz (liquide)
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).
Between April 6 and 11, 2008, the owner applied an incorrect dose of the product to the dog as a preventative measure.
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
Miniature Dachshund
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
14.6
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
Unknown / Inconnu
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- Symptom - Lesion
- Specify - Papules
- Gastrointestinal System
- Symptom - Bloody diarrhea
- General
- Symptom - Parasitism
- Specify - Parasitism
- Blood
- Symptom - Thrombocytopenia
- Specify - Immune-mediated thrombocytopenia
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Yes
14. a) Was the animal hospitalized?
Yes
14. b) How long was the animal hospitalized?
4
Day(s) / Jour(s)
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
The APSS veterinarian recommended that the attending veterinary staff supply supportive and symptomatic care to the animal; give fluid therapy; perform a chemistry profile and a complete blood count; and give prednisone, gastrointestinal protectants, and antibiotics. The animal was diagnosed with alopecia, papules, parasites, bloody diarrhea, and immune-mediated thrombocytopenia. While at the veterinary clinic the animal was bathed, remained on fluid therapy, received a blood transfusion, and was monitored for central nervous system signs. Diagnostic blood work was performed; gastrointestinal protectants and prednisone were administered; and symptomatic and supportive cares were provided. Despite the veterinary clinic's efforts, the animal died on April 18, 2008.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
Product not used according to label directions. Incorrect dosage used. A necropsy was not performed because clinic determined the product was not the cause of death.