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Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2019-0714
2. Registrant Information.
Registrant Reference Number: USA-BAYERBAH-2018-US0016596 (Report 481727)
Registrant Name (Full Legal Name no abbreviations): Bayer inc
Address: 2920 Matheson Blvd
City: Mississaugua
Prov / State: ON
Country: Canada
Postal Code: L4W 5R6
3. Select the appropriate subform(s) for the incident.
Domestic Animal
4. Date registrant was first informed of the incident.
27-APR-185. Location of incident.
Country: UNITED STATES
Prov / State: MONTANA
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. 11556-186
Product Name: Clean Up II Pour-On (unspecified)
- Active Ingredient(s)
- DIFLUBENZURON
- Guarantee/concentration 3 %
- PERMETHRIN
- Guarantee/concentration 5 %
- DIFLUBENZURON
7. b) Type of formulation.
Other (specify)
Pour OnApplication 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).
On approximately 15-Nov-2017, six bovine, of unknown signalment and condition, with no known concomitant medical conditions, were administered an unknown amount of Clean Up II Pour-On (unspecified) (Permethrin-Diflubenzuron) topically by the producer.To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform III: Domestic Animal Incident Report
1. Source of Report
Animal's Owner
2. Type of animal affected
Cow / Vache
specify Cattle
3. Breed
Unknown
4. Number of animals affected
6
5. Sex
Unknown
6. Age (provide a range if necessary )
Unknown
7. Weight (provide a range if necessary )
Unknown
8. Route(s) of exposure
Skin
9. What was the length of exposure?
>1 wk <=1 mo / > 1 sem < = 1 mois
10. Time between exposure and onset of symptoms
Unknown / Inconnu
11. List all symptoms
System
- General
- Symptom - Death
- Skin
- Symptom - Hair loss
- Symptom - Pruritus
12. How long did the symptoms last?
Unknown / Inconnu
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
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 unknown date, in Dec 2017, all of the cattle exhibited hair loss and rubbing. On unknown date post onset, in approximately 2017, the cattle died. No necropsy was performed. No further information is expected. This case is closed.
To be determined by Registrant
18. Severity classification (if there is more than 1 possible classification
Death
19. Provide supplemental information here
N - Unlikely On 15 NOV 2017, six bovine, of unknown signalement and condition were administered an unknown amount of Clean Up II Pour-on topically by the producer. On an unknown date in DEC 2017, all the bovine exhibited pruritus and alopecia. On an unknown date post onset, in DEC 2017, the cattle died. No necropsy was carried out. Reported clinical signs, particularly death, are not expected with appropriate topical use of product as inconsistent with the pharmaco-toxicological product profile. The correctness of dosage is not appraisable as treatment and animal details not provided. However, even some minor Information missing, due to the much too long time to onset of at least two weeks any product involvement can be exclusded and case assessed as unlikely. (N)
