Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-8006

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0071645 (Report 457412)

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.

03-NOV-17

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

06-OCT-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. 11556-152

Product Name: Advantage II Large 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.

.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 22-Sep-2017, a 12 week old, 1 pound, intact, male, Himalayan feline, in unknown condition, with concomitant fleas, was administered a partial tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner. This was an off label use as the cat did not meet the minimum weight for the product.

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

Himalayan

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.229

7. Weight (provide a range if necessary )

0.454

kg

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

>1 wk <=1 mo / > 1 sem < = 1 mois

11. List all symptoms

System

• Respiratory System
  • Symptom - Difficulty Breathing

• General
  • Symptom - Pale mucous membrane colour
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Yes

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 06Oct2017, the feline was having breathing difficulties and pale gums. The feline was examined by a veterinarian and administered an unknown dose of furosemide. The feline died approximately 3 hours after the furosemide was administered. No necropsy was performed.

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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

N - Unlikely This is an off-label use as cat did not meet the minimum weight for the product and likely a larger dose was applied. Difficulty in breathing and pale gums are not anticipated after topical product application. Other causes must be considered. Death is not expected after product application, as inconsistent 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. Time to onset of signs is too long. Moreover, the reason for the initial phone call was to discuss the use of the product and not to report the death of the patient. The animal was very young and was concomitantly administered another product. Death occurred in close proximity with the administration of the other applied product. Though no necropsy was performed, considering long time to onset, intent of the call and known product safety profile, a product relation is considered unlikely.