Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2018-5532
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0055618 (Report 521316)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson BLVD
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L5W5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
18-SEP-18
5. Location of incident.
Country: UNITED STATES
Prov / State: VIRGINIA
6. Date incident was first observed.
Unknown
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.
PMRA Submission No.
EPA Registration No. 11556-155
Product Name: Seresto collar
- Active Ingredient(s)
- FLUMETHRIN
- Guarantee/concentration 4.5 %
- IMIDACLOPRID
- Guarantee/concentration 10 %
7. b) Type of formulation.
Other (specify)
COLLAR
Application Information
8. Product was applied?
Yes
9. Application Rate.
1
Other Units: collar
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 an unspecified date in approximately Jun-2018, a 14 year old, approximately 3 pound, neutered, female, Chihuahua dog, in unknown condition, with concomitant medical conditions of weight loss, anorexia and renal failure, had one Seresto Small Dog collar (Flumethrin-Imidacloprid) placed around the neck by the animal owner.
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
Animal's Owner
2. Type of animal affected
Dog / Chien
3. Breed
Chihuahua
4. Number of animals affected
1
5. Sex
Female
6. Age (provide a range if necessary )
14
7. Weight (provide a range if necessary )
1.361
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
>2 mos <=6 mos / > 2 mois < = 6 mois
11. List all symptoms
System
- Gastrointestinal System
- Symptom - Weight loss
- Symptom - Anorexia
12. How long did the symptoms last?
Persisted until death
13. Was medical treatment provided? Provide details in question 17.
Unknown
14. a) Was the animal hospitalized?
Unknown
14. b) How long was the animal hospitalized?
15. Outcome of the incident
Died
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 approximately 15-Sep-2018, the dog died. No Necropsy was performed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
No assessment performed - The intent of the call was not to report death but to inquire of a refund. This case remains open.