Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5069

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0045835 (Report 588564)

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-19

5. Location of incident.

Country: UNITED STATES

Prov / State: TEXAS

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)

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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 %

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

Product Name: Advantage Spot-on pipette size unknown

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

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7. b) Type of formulation.

Other (specify)

spot on

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 2010, a cat with unknown signalment, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (cat-unspecified) (Imidacloprid) via the topical route by the animal owner.On an unspecified date in 2015, the cat was administered 1 tube of Advantage II (cat-unspecified) (Imidacloprid-Pyriproxyfen) via the topical route 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

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
  • Symptom - Other
  • Specify - Thyroid gland disorder NOS

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 an unspecified date in 2015, post application, the cat developed a thyroid disorder NOS. It was unknown if the cat was examined or treated by a veterinarian. On an unspecified date post application and post onset of the clinical sign, in 2015, the cat died. It is not known if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant details were not obtained, nor will such be sought. The intent of the call was to inquire about product use in general and not to report this event. No further information is expected. This case is closed.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Advantage Plus Spot-on pipette size unknown O - Unclassifiable/unassessable Reported thyroid disorder and death are not expected with topical product application. They are not consistent with pharmaco-toxicological product profile. 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. Additionally, the intent of the call was to inquire about product use in general and not to report this event. However time to onset is unknown. Other causes must be considered. Overall, product relation for the case is unassessable. Advantage Spot-on pipette size unknown N - Unlikely Reported thyroid disorder and death are not expected with topical product application. They are not consistent with pharmaco-toxicological product profile. 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. Additionally, the intent of the call was to inquire about product use in general and not to report this event. Time to onset is too long (5 years). Overall, a product relation for the case is considered unlikely.