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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-7174
2. Registrant Information.
Registrant Reference Number: 120157667
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.
12-NOV-125. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
01-NOV-12Product 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. 26494 PMRA Submission No. EPA Registration No.
Product Name: Zodiac Powerspot Flea And Tick Control For Dogs Under 14 kg
- Active Ingredient(s)
- (S)-METHOPRENE
- PERMETHRIN
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1Units: 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 1, 2012 the owner applied the product to two dogs to treat for fleas.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
YesSubform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Chihuahua
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
10.5
7. Weight (provide a range if necessary )
6.5
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
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Nervous and Muscular Systems
- Symptom - Head shaking
- Skin
- Symptom - Erythema
- General
- Symptom - Vocalizing
12. How long did the symptoms last?
Unknown / Inconnu
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
Unknown/Inconnu
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 1, 2012 the owner noticed that the dog had pruritus and was shaking his head. On November 4, 2012 the owner noticed that the dog had erythema and was vocalizing. On November 7, 2012 the owner took the dog to the veterinarian, where the dog was bathed with a sample shampoo and liquid dish washing detergent (LDWD). The owner was also sent home with a shampoo product to use on the dog. On November 9, 2012 the owner noticed that all of the dog's signs except for the head shaking had ended. On November 12, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician stated that some animals can be more sensitive to the product's ingredients and experience a dermal reaction, but that the head shaking would not be expected to persist. The APSS technician recommended that the owner apply vitamin E to the application area, monitor the dog at home for continued signs, take the dog to the veterinarian if signs persisted, and call back with questions. The APSS technician also referred the owner to the product's manufacturer to discuss a refund.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Chihuahua
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
1.0
7. Weight (provide a range if necessary )
5.0
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
>30 min <=2 hrs / >30 min <=2 h
11. List all symptoms
System
- Skin
- Symptom - Pruritus
- Nervous and Muscular Systems
- Symptom - Head shaking
- Skin
- Symptom - Erythema
- General
- Symptom - Vocalizing
12. How long did the symptoms last?
Unknown / Inconnu
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
Unknown/Inconnu
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 1, 2012 the owner noticed that the dog had pruritus and was shaking his head. On November 4, 2012 the owner noticed that the dog had erythema and was vocalizing. On November 7, 2012 the owner took the dog to the veterinarian, where the dog was bathed with a sample shampoo and liquid dish washing detergent (LDWD). The owner was also sent home with a shampoo product to use on the dog. On November 9, 2012 the owner noticed that all of the dog's signs except for the head shaking had ended. On November 12, 2012 the owner contacted the Animal Product Safety Service (APSS) to obtain help. The APSS technician stated that some animals can be more sensitive to the product's ingredients and experience a dermal reaction, but that the head shaking would not be expected to persist. The APSS technician recommended that the owner apply vitamin E to the application area, monitor the dog at home for continued signs, take the dog to the veterinarian if signs persisted, and call back with questions. The APSS technician also referred the owner to the product's manufacturer to discuss a refund.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
