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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-3239

2. Registrant Information.

Registrant Reference Number: US-BAYERBAH-2017-406619

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.

01-JUN-17

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. Unknown

Product Name: advantage II pipette size unknown

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

7. b) Type of formulation.

Other (specify)

Spot-on solution

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).

Animal body weight unknown, and exact pipette size is not clear for the animal.

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

Cat / Chat

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

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?

Other / Autre

specify Unknown

17. Provide any additional details about the incident

(eg. description of the frequency and severity of the symptoms

2016-08-25 13:47:24 by (name) : Call Notes: Caller was difficult to follow. She reported that three of her cats died that previously used the medication but was not calling to report a fatality. She was wondering if the product had an expiration date. She also was confused and that we were also 1-800 Pet Meds and was trying to ask about ordering. Reason for use of drug: Adverse Reaction-Other Reproductive status: Unknown Place of purchase: Other Animal to animal exposure?: Unknown Misuse: NA/Unknown Case status: Closed No more information is expected. The case is closed. No known necropsy was performed. Call Review: Both large and small cat products were found in a drawer from previous pets. She did not clarify which of the products were used on each of the cats that had died.


To be determined by Registrant

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

Death

19. Provide supplemental information here

N - Unlikely Death is not expected as inconsistent with pharmacotoxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24- fold overdosage tolerated by cats without showing any side effect. No signs of allergic/anaphylactic reaction reported. Moreover, the information regarding the death of the cat was casually provided during an inquiry, which too was possibly intended for another organisation (Pet meds). Finally, even though some information (e.g. time to onset, necropsy results, particular of the animal, pipette size) was missing, considering known product profile and intent of caller, a product involvement is deemed to be unlikely.