Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-3602

2. Registrant Information.

Registrant Reference Number: 2016KP019

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.

04-MAY-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

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. 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.

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 an unknown date in 2012, a 5.5 year old, 14 pound,neutered, female, Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) topically by the owner

To be determined by Registrant

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

Yes

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Shorthair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

5.5

7. Weight (provide a range if necessary )

14

lbs

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

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Weight loss

• Liver
  • Symptom - Other
  • Specify - Hepatic Neoplasm - Liver tumour

• Renal System
  • Symptom - Renal failure

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?

No

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 unknown date post application, in 2012, the cat had a weight loss of 6 pounds. On an unknown date post application, in 2012, the cat was examined by a veterinarian, diagnosed with a liver tumor, administered an unknown anesthesia and the veterinarian performed an ultrasound guided needle biopsy of the liver tumor. The cat was released that evening. On an unknown date post diagnosis, in 2012, the cat returned to the veterinarian and was diagnosed with renal failure. On an unknown date in 2012, the cat died at home. No necropsy was performed. No more information expected. This case is closed. Note: Previous application is well tolerated by the cat.

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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

Weight loss is not expected after product application as inconsistent with pharmaco toxicological product profile. In this case it may related to later diagnosed liver tumor and renal failure. Liver tumor, renal failure and subsequent death are also not expected after product application, as inconsistent with pharmaco-toxicological product profile. No signs of allergic/anaphylactic reaction reported. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Cat likely died due to underlying medical condition of liver tumor and renal failure. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after (approximately 4 years). Additionally, previous application is well tolerated by the cat. Finally, even though some information (e.g. time to onset and necropsy results) missing, considering known product profile and unexpected fetal outcome, a product involvement is deemed to be unlikely.