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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2311

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0018302 (Report 483683)

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.

07-MAY-18

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

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. Unknown

Product Name: Advantix Plus Spot-on pipette size unknown

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %
    • PYRIPROXYFEN
      • Guarantee/concentration .44 %

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar unknown

  • Active Ingredient(s)
    • FLUMETHRIN
      • Guarantee/concentration 4.5 %
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

7. b) Type of formulation.

Other (specify)

Spot-on and 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 unknown date in 2015, a canine of unknown signalment, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of K9 Advantix II (unspecified) (Imidacloprid-Permethrin-Pyriproxyfen) topically by the owner once monthly. On an unknown date in 2016, the K9 Advantix II was discontinued and the canine had 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar placed around the neck by the owner. The canine had a new Seresto collar applied approximately every 8 months by the owner with the most recent having been applied on an unknown date in 2017.

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

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?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Neoplasia

12. How long did the symptoms last?

Persisted until death

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 an unknown date in 2017, the canine was diagnosed with an unspecified neoplasia and died. No known necropsy was performed. No further information is expected. Case is closed. The intent of the call was to discuss product use on new pets and not to report the death of the canine.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

N - Unlikely Reported neoplasia and death not expected in dog after product application, as inconsistent with pharmaco-toxicological product profile. The intent of the call was to discuss product use on new pets and not to report the death of the canine and thus no product relation seen by owner. Last product application in 2016 however clinical signs and death occurred in 2017 and thus approximately one year after last product administration. No signs of allergy/anaphylactic reaction reported which would have occurred much earlier after product use. Considering all aspects, a product connection deemed to be unlikely. N - Unlikely Reported unspecified neoplasia and death is not expected following appropriate topical product application as inconsistent with product's pharmacological profile. Death probably the consequence of diagnosed neoplasia. Oral exposure to the collar is not expected to cause serious signs. No signs of anaphylaxis reported which would have occurred in close proximity to the collar application. None of the product's active ingredients has cancerogenic potential. Time to onset unknown, however the intent of the call was to discuss product use on new pets and not to report the death of the canine and thus no product relation seen by owner. In the end, sufficient information exists to rule out product involvement. Overall, a product connection is considered unlikely.