Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2013-2009
2. Registrant Information.
Registrant Reference Number: 2013TH009
Registrant Name (Full Legal Name no abbreviations): Bayer Inc
Address: 77 Belfield Rd
City: Toronto
Prov / State: ON
Country: Canada
Postal Code: M9W 1G6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
28-FEB-13
5. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
14-NOV-12
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. 25129
PMRA Submission No.
EPA Registration No.
Product Name: advantage 18
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8
Units: 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).
Product was applied between the shoulder blades, not to the back of the neck as instructed.
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
Cat / Chat
3. Breed
Domestic short hair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
11
7. Weight (provide a range if necessary )
6.1
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 mo <= 6 mos / > 1 mois < = 6 mois
10. Time between exposure and onset of symptoms
>24 hrs <=3 days / >24 h <=3 jours
11. List all symptoms
System
- Skin
- Symptom - Hair loss
- Symptom - Itchy skin
- Symptom - Lesion
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?
No
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Not recovered / Non rétabli
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
Product was applied as fleas were found on dog in same house. Applied Nov 12 2012. Owner noticed application site alopecia Nov 14 2012. Called clinic to report. 2009 similar hair loss seen after advantage. Pet examined Dec 14 as area is not healing. On exam Dec 14 DVM noted interscapular alopecia, pruritus, crusting and ulceration. Area was washed and fuciderm prescribed for topical treatment. Hair had started to regrow but cat is traumatizing area by scratching. Owner reports cat improved Dec 18 2013. Cat seen again Jan 30 2013 as area is not healed. Cat scratches it open whenever owner doesnt cover it with stockinette. Depomedrol injection given. Feb 8, owner reports cat isnt better. Feb 20, no change. Cat has scratched the area open again. Feb 26, pet examined again, small scab at application site but skin is not thickened. Alopecic still. Veterinarian recommended to keep area covered and will add oral antibiotics and gabapentin to therapy.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here