Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-5177
2. Registrant Information.
Registrant Reference Number: 2012TH129
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.
14-SEP-12
5. Location of incident.
Country: CANADA
Prov / State: PRINCE EDWARD ISLAND
6. Date incident was first observed.
13-SEP-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. 25131
PMRA Submission No.
EPA Registration No.
Product Name: advantage 100
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
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).
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 long hair
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
14
7. Weight (provide a range if necessary )
2.5
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>8 hrs <= 24 hrs / >8 h <= 24 h
10. Time between exposure and onset of symptoms
>2 hrs <=8 hrs / > 2 h < = 8 h
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Drooling
- Symptom - Loss of appetite
- Nervous and Muscular Systems
- Symptom - Muscle trembling
- Symptom - Staggering
- Blood
- Symptom - Other
- Specify - mild hemoconcentration
- Liver
- Symptom - Elevated liver enzymes
- Specify - mildly elevated ALT
- Nervous and Muscular Systems
- Symptom - Muscle twitching
- Gastrointestinal System
- Symptom - Anorexia
- Specify - not eating
- General
- Symptom - Adipsia
- Specify - not drinking
12. How long did the symptoms last?
>24 hrs <=3 days / >24 h <=3 jours
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?
48
Hour(s) / Heure(s)
15. Outcome of the incident
Fully Recovered / Complètement 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
Owner split tube of advantage 100 between 2 cats the evening of Sept 13 2012. The evening the owner noticed that this cat was lethargic. The cat was not eating or drinking. The cat was drooling. The owner also noted staggering and twitching. The pet was presented to a veterinarian Sept 14. Bloodwork and urine was collected. On exam the pet seemed to be dull but all else examined normal other than a heart murmur ranked as 1.5/6. Bloodwork showed mild hemoconcentration, mildly elevated ALT (was elevated in June of 2012 as well), and a urine SG of 1.0508. All else was normal. No twitching was seen until after 11 PM the evening of Sept 14 when the DVM noted the cat was shaking and seemed to tremble worse when stimulated. The shaking had resolved by the next morning.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here