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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2015-0814
2. Registrant Information.
Registrant Reference Number: 140158781
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-DEC-145. Location of incident.
Country: UNITED STATES
Prov / State: UNKNOWN
6. Date incident was first observed.
14-DEC-14Product 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. 2724-797-89459
Product Name: Bio Spot Active Care Flea And Tick Spray For Dogs And Puppies
- Active Ingredient(s)
- (S)-METHOPRENE
- Guarantee/concentration .27 %
- ETOFENPROX
- Guarantee/concentration .5 %
- PIPERONYL BUTOXIDE
- Guarantee/concentration 1.75 %
- (S)-METHOPRENE
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
10. Site pesticide was applied to (select all that apply).
Site: Res. - In Home / Rés. - à l'int. maison
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
On December 13, 2014 the owner inappropriately sprayed the product onto the puppy's bed and did not let the product dry before letting the puppy on the bed. The dog was on the bed for an hour before being put into a crate to sleep.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
Female
6. Age (provide a range if necessary )
0.15
7. Weight (provide a range if necessary )
2.5
lbs
8. Route(s) of exposure
Skin
Oral
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Vomiting
- Symptom - Diarrhea
- Symptom - Loss of appetite
- General
- Symptom - Adipsia
- Symptom - Lethargy
- 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?
Contact treat.area/Contact surf. traitée
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
On December 14, 2014 the owner found the puppy was symptomatic. That evening, the owner called the Animal Product Safety Service (APSS). The APSS veterinarian stated the risk is for mild gastrointestinal (GI) upset or dermal irritation. The APSS technician recommended the owner take the puppy to the veterinarian, have the veterinarian call for information, and call back with questions. The owner was hesitant to take the puppy to vet due to financial concerns.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
On December 16, 2014 an APSS assistant called the owner to follow-up. The owner stated the puppy died a few hours after the initial call to the APSS on December 14, 2014. The owner stated she did not take the puppy to the clinic, but did try to give the puppy water. The owner declined speaking with one of the APSS veterinarians. Extra label use- product not labeled for use on pet bedding. Puppy was too young for product use.
