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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-2678
2. Registrant Information.
Registrant Reference Number: 2012TH024
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.
23-APR-125. Location of incident.
Country: CANADA
Prov / State: ONTARIO
6. Date incident was first observed.
22-APR-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. 25129 PMRA Submission No. EPA Registration No.
Product Name: advantage 18
- Active Ingredient(s)
- IMIDACLOPRID
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
.8Units: 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).
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
Medical Professional
2. Type of animal affected
Cat / Chat
3. Breed
Domestic short hair
4. Number of animals affected
1
5. Sex
Male
6. Age (provide a range if necessary )
12
7. Weight (provide a range if necessary )
7.24
kg
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- General
- Symptom - Loss of balance
- Eye
- Symptom - Other
- Specify - eyes were twitching
- Nervous and Muscular Systems
- Symptom - Muscle tremors
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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
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
Oscar is a 12 yr old MN DSH 7.24 kg. He was outdoors for a few days prior to April 22. He returned home the evening of April 21 and at 8 AM April 22 the owners applied a tube of advantage 18. Owner reports this was the last in the box. The other cat, Monroe, 3 yr old DSH FS 5.1 kg, was observed licking Oscar. At 3 PM Oscar was wobbling and his eyes were twitching, at 8 PM he presented to the emergency clinic with tremors. He was treated with methocarbamol at 9 PM and discharged with oral methocarbamol. On the return home, Monroe was noted to be twitching and was worse than Oscar. Monroe was hospitalized on IV fluids and injectable methocarbamol and sent home April 23 with methocarbamol tablets. The veterinarian feels that someone may have put something on Oscar when he was away from home. Bayer called the regular DVM to confirm purchase history, the rDVM feels the product was likely purchased on the internet as they know these clients have purchased internet product before and the clinic has not sold them advantage since 2009. Emergency vet saw the box and said it looked like advantage but didn't see the tube. Vet still thinks maybe someone else put something else on the cat before the advantage.
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
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 )
3
7. Weight (provide a range if necessary )
5.1
kg
8. Route(s) of exposure
Oral
9. What was the length of exposure?
>24 hrs <=3 days / >24 h <=3 jours
10. Time between exposure and onset of symptoms
>8 hrs <=24 hrs / > 8 h < = 24 h
11. List all symptoms
System
- Nervous and Muscular Systems
- Symptom - Muscle twitching
12. How long did the symptoms last?
>8 hrs <=24 hrs / > 8 h < = 24 h
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?
1
Day(s) / Jour(s)
15. Outcome of the incident
Fully Recovered / Complètement rétabli
16. How was the animal exposed?
Accidental ingestion/Ingestion accident.
17. Provide any additional details about the incident
(eg. description of the frequency and severity of the symptoms
Oscar is a 12 yr old MN DSH 7.24 kg. He was outdoors for a few days prior to April 22. He returned home the evening of April 21 and at 8 AM April 22 the owners applied a tube of advantage 18. Owner reports this was the last in the box. The other cat, Monroe, 3 yr old DSH FS 5.1 kg, was observed licking Oscar. At 3 PM Oscar was wobbling and his eyes were twitching, at 8 PM he presented to the emergency clinic with tremors. He was treated with methocarbamol at 9 PM and discharged with oral methocarbamol. On the return home, Monroe was noted to be twitching and was worse than Oscar. Monroe was hospitalized on IV fluids and injectable methocarbamol and sent home April 23 with methocarbamol tablets. The veterinarian feels that someone may have put something on Oscar when he was away from home. Bayer called the regular DVM to confirm purchase history, the rDVM feels the product was likely purchased on the internet as they know these clients have purchased internet product before and the clinic has not sold them advantage since 2009. Emergency vet saw the box and said it looked like advantage but didn't see the tube. Vet still thinks maybe someone else put something else on the cat before the advantage.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
