Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-4183

2. Registrant Information.

Registrant Reference Number: 2016KP087

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.

18-JUL-16

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

16-APR-16

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. 11556-150

Product Name: advantage II kitten

• 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.

.2

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 15-Apr-2016, a 14 year old, 10 pound, neutered, female,Domestic Shorthair feline, in good condition, with no known concomitant medical conditions, was administered 1 tube ofAdvantage II Kitten (Imidacloprid-Pyriproxyfen) topically by the owner.

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

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 )

14

7. Weight (provide a range if necessary )

10

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

>24 hrs <=3 days / >24 h <=3 jours

11. List all symptoms

System

• General
  • Symptom - Death

• Gastrointestinal System
  • Symptom - Anorexia

• Renal System
  • Symptom - Renal failure

• Gastrointestinal System
  • Symptom - Weight loss

• Renal System
  • Symptom - Other
  • Specify - Elevated renal parameters

12. How long did the symptoms last?

>3 days <=1 wk / >3 jours <=1 sem

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 16 Apr 2016, the cat had anorexia. On 18 Apr 2016, the cat was examined by a veterinarian and blood work was performed, which revealed elevated renal values. The cat was diagnosed with renal failure and had a 5 pound weight loss. On 19 Apr 2016, the cat died at home. No known necropsy was performed. No further information 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

Anorexia is unspecific sign and may have numerous other causes in cat. Elevated renal values and weight loss likely related to later diagnose renal failure. Renal failure and death are not expected after product application as inconsistent with pharmacotoxicological product profile. Nevertheless death is inconsistent with pharmacotoxicological product profile and experience. 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. Most likely the cat died of old age and renal disease. Though time to onset is short for initial sign it is long (4 days) for serious sign. Finally, even though some information (e.g. necropsy results) missing, considering the most prominent sign death which characterizes this case, no plausible connection can be made to the product and a product relation is deemed to be unlikely.