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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5460

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0044319 (Report 510312)

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.

06-AUG-18

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

06-AUG-18

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. 11556-168

Product Name: Permectrin Fly & Louse Dust

  • Active Ingredient(s)
    • PERMETHRIN
      • Guarantee/concentration .25 %

7. b) Type of formulation.

Dust

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).

On an unspecified date in approximately Aug 2018, a female, Chicken, of unknown signalment, in unknown condition, with a concomitant unspecified systemic condition and had fly maggots, was administered an unknown amount of Permectrin Fly Louse Dust (2 pound shaker can) (Permethrin) topically by the owner for the fly maggots. This is an extra-label use of the product as it is not indicated for treatment of fly maggots on chickens.

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

Animal's Owner

2. Type of animal affected

Bird - Poultry / Oiseau - Volaille

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Female

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death

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 approximately 06Aug2018, the chicken died. No known medical intervention was sought and no known necropsy examination was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial call was to discuss proper disposal of the product and not to report the death in this event. 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

O - Unclassifiable/unassessable On an unspecified date in approximately Aug 2018, a female, Chicken, of unknown signalment, in unknown condition, with a concomitant unspecified systemic condition and had fly maggots, was administered an unknown amount of Permectrin Fly & Louse Dust topically by the owner for the fly maggots. Off-label use as product it is not indicated for treatment of fly maggots on chickens. On approximately 06 AUG 2018, the chicken died. No known medical intervention was sought and no known necropsy examination was performed. Correctness of dosage is not appraisable as animal or treatment details not provided. Death is not expected after topical application of product as inconsistent with the pharmaco-toxicological product profile. The product has a wide margin of safety. The dermal LD50 in the rat is 4,000 mg/kg bw. It is unknown if skin of the application site was intact. The reason for the initial call was to discuss proper disposal of the product and not to report the death in this event. A causal connection with the product is rather unlikely but available information is absolutely insufficient for a reliable causality assessment as no timeline, as well as no treatment or animal details communicated. (O)