Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2012-3788
2. Registrant Information.
Registrant Reference Number: 2012TH089
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.
03-JUL-12
5. Location of incident.
Country: CANADA
Prov / State: QUEBEC
6. Date incident was first observed.
25-JUN-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. 25132
PMRA Submission No.
EPA Registration No.
Product Name: advantage 20
7. b) Type of formulation.
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
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).
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Yes
Subform III: Domestic Animal Incident Report
1. Source of Report
Medical Professional
2. Type of animal affected
Dog / Chien
3. Breed
Pomeranian
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
6
7. Weight (provide a range if necessary )
6.6
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
>1 wk <=1 mo / > 1 sem < = 1 mois
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Loss of appetite
- Symptom - Weight loss
- Symptom - Vomiting
- Renal System
- Symptom - Creatinine increased
- Blood
- Symptom - Other
- Specify - albumin increased
- General
- Symptom - Dehydration
- Specify - mild dehydration
- Blood
- Symptom - Thrombocytopenia
- Specify - decreased platelets
- Symptom - Other
- Specify - Increased HCT
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
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
Pet owner treated pet sometime in June with advantage 20. The date is unknown. June 27 the owner presented the pet to the clinic as the dog had not eaten well in 3 days and vomited once. The differential diagnosis was viral or parasitic gastroenteritis, pancreatitis and dietary indescretion. Bloodwork was done that showed increase HCT and decreased platelets but clumping was present. Albumin was increased, ALP was decreased and creatinine was increased. A SNAP cPLi was negative. Mild dehydration was noted. A radiograph was recommended and the owner declined. Pepcid was prescribed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Moderate
19. Provide supplemental information here