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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5540

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0057128 (Report 523559)

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.

20-SEP-18

5. Location of incident.

Country: UNITED STATES

Prov / State: WASHINGTON

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 %

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: advantageII pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Liquid

Other (specify)

COLLAR

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 Jun-2018, a male, Unknown dog, of unknown signalment, in unknown condition, with concomitant medical condition of fleas, was administered 1 tube of Advantage II (dog-unspecified) (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner.On a later unspecified date in approximately Jun-2018, the dog developed pruritus. The dog was bathed by the animal owner in an unspecified flea shampoo. The animal continued to bathed the dog monthly in the same unspecified flea shampoo product.On an unspecified date in approximately Jul-2018, the animal owner reapplied one tube of Advantage II (dog unspecified) topically to the dog.On approximately 09-Aug-2018, the dog had one Seresto Dog (unspecified) (Flumethrin-Imidacloprid) Collar 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Dog / Chien

3. Breed

unknown

4. Number of animals affected

1

5. Sex

Male

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 mo <= 6 mos / > 1 mois < = 6 mois

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Pruritus

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 06-Sep-2018, the dog passed away. 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 the perceived lack of efficacy for the other three dogs and not to report the death in this event. 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 - Information was collected during an inquiry of a customer where information regarding the product, e.g. perceived lack of efficacy for the other three dogs, was discussed. Clinical information including death was mentioned in this call but were not considered to be product related, neither by customer nor by the MAH