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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-5516

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0052533 (Report 518845)

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-SEP-18

5. Location of incident.

Country: UNITED STATES

Prov / State: GEORGIA

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. 11556-151

Product Name: advantageII small cat

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

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-152

Product Name: advantageII large cat

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

7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.8

Units: mL

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 approximately Jun 2017, a cat, of unknown signalment and condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. On approximately 26-Aug-2018, 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) was applied 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

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

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

Approximately one year post application of advantageII small cat, in Jun-2018, the cat developed generalized pruritus. On approximately 4 days post application of advantageII large cat, 30-Aug-2018, the cat died. No known 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

Advantage Plus Spot-on 0.4 ml (40 mg Imi / 2 mg Pyri) Cat <= 4 kg : N - Unlikely Generalized pruritus or pruritus on other than the application site is not anticipated with topical product administration. If any, skin reactions would be localized at the application site. Time to onset is exceptionally long for pruritus. Death reported after reapplication of the different pipette size of the product. Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Moreover, the initial call to Bayer Animal Health was to discuss product use on another cat and not to report the death in this event. Time to onset is long. Overall, a product relation is unlikely. Advantage Plus Spot-on 0.8 ml (80 mg Imi / 4 mg Pyri) Cat > 4 kg : N - Unlikely Pruritus was reported on previous product application before a year hence not related to the product. Death reported after reapplication of the different pipette size of the product. Death is inconsistent with pharmaco-toxicological product profile and experience. Product has wide margin of safety. Oral LD50 in rat is 642 mg/kg BW. 24-fold over dosage tolerated by cats without showing any side effect. Moreover, the initial call to Bayer Animal Health was to discuss product use on another cat and not to report the death in this event. Time to onset is long. Overall, a product relation is unlikely.