Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-6942

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0060956 (Report 447010)

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.

18-SEP-17

5. Location of incident.

Country: UNITED STATES

Prov / State: NEW YORK

6. Date incident was first observed.

23-AUG-17

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. 11556-151

Product Name: Advantage II Small Cat

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

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7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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).

A 16 year old, approximately 10 pound, neutered, male, Birman (Sacred Birman) cat, was administered a partial tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner (Unauthorised dosage- Low dose).

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Birman (Sacred Birman)

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

16

7. Weight (provide a range if necessary )

4.536

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>8 hrs <= 24 hrs / >8 h <= 24 h

10. Time between exposure and onset of symptoms

>8 hrs <=24 hrs / > 8 h < = 24 h

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Seizure

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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 22-Aug-2017, a 16 year old, approximately 10 pound, neutered, male, Birman (Sacred Birman) cat, in unknown condition, with a concomitant medical condition of fleas, was administered a partial tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) via the topical route by the animal owner. This product is not labeled for partial tube application, nor is it labeled for application on cats weighing more than 9 pounds. On 23-Aug-2017, the cat exhibited multiple seizure episodes. The cat was examined by a veterinarian who hospitalized the cat for continued observation and the cat died. No necropsy was performed. No further information is expected; the case is closed. On Aug 2017 the cat was also administered unknown of via the unknown route by the animal owner.

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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

O - Unclassifiable/unassessable Serious nervous system disorders such as seizures are not anticipated with topical administration of Advantage II. From a toxicological point of view, neither imidacloprid nor pyriproxyfen does have the potential to provoke seizures in vertebrates. No oral product exposure is reported. Death is inconsistent with pharmaco-toxicological product profile and experience. No signs of allergic/anaphylactic reaction reported. 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. In this case, a tool low dose of product was applied which makes product involvement even more unlikely. Involved animal was geriatric, thus other underlying conditions must be considered. Time to onset is short, though. Finally, a product involvement is considered as unassessable.