Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2008-1153
2. Registrant Information.
Registrant Reference Number: 070114866
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.
31-OCT-07
5. Location of incident.
Country: UNITED STATES
Prov / State: NEW JERSEY
6. Date incident was first observed.
30-OCT-07
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 16-30 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).
On October 26, 2007 the owner applied the product to her dog as a preventative measure.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Beagle
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
4.5
7. Weight (provide a range if necessary )
24
lbs
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>3 days <=1 wk / >3 jours <=1 sem
10. Time between exposure and onset of symptoms
>3 days <=1 wk / >3 jours <=1 sem
11. List all symptoms
System
- Nervous and Muscular Systems
- General
- Symptom - Swelling
- Specify - Swelling in neck (throat area)
- Symptom - Subdued
- Symptom - Death
12. How long did the symptoms last?
>3 days <=1 wk / >3 jours <=1 sem
13. Was medical treatment provided? Provide details in question 17.
Yes
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?
Treatment / Traitement
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On October 31, 2007, the owner was advised to take the animal into the local veterinary clinic for a physical exam and a diagnostic evaluation. The APSS staff member suggested the owner have the attending veterinary contact the APSS for additional recommendations, if needed. On November 6, 2007, the owner advised APSS staff member that she noticed a swelling around the dog's throat on November 1, 2007. The owner also reported that the dog had died and was cremated on November 2, 2007. She stated that her regular veterinarian had described a circulatory condition as potential cause. Based on the description, the APSS veterinarian suspected that the dog had Immune Mediated Hemolytic Anemia.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
It is unknown if product was used according to label directions which states contact veterinarian before using on medicated animals. The animal was on seizure medication. APSS veterinarian suspected that the dog had Immune Mediated Hemolytic Anemia which contributed to the cause of death.