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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-4020

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0022358

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.

30-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

09-MAY-17

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. Unknown

Product Name: Permectrin II Spray

  • Active Ingredient(s)
    • Permethrin
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

spray

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).

An unknown amount of Permectrin II Spray (Permethrin) was administered topically by the owner.

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

Other Chicken

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.416

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Unknown

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

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.

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 08-May-2017, two, 5 month old, male, Chicken - Layer avian, in unknown condition, with concomitant medical conditions of mites, was administered an unknown amount of Permectrin II Spray (Permethrin) topically by the owner. The chicken was dunked in a bucket with approximately 1 ounce of product in 3 gallons of water for treatment of suspected mites. On 09-May-2017, one chicken was found deceased. 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

O - Unclassifiable/unassessable Reported sign is not expected after topical application of product as inconsistent with the pharmaco-toxicological product profile. No signs of pyrethroid toxicity (e.g. ataxia, CNS excitation, seizures) reported. Information missing on exact final dosing solution and whether product was accidentally ingested. Moreover, animals were not sprayed, but dipped which is not recommended. Thus, overdose and/or oral ingestion cannot be excluded. Time to onset consistent. No necropsy performed. Overall, case is inconclusive and is considered unclassifiable.