Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2016-2713

2. Registrant Information.

Registrant Reference Number: 2016KP031

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.

02-OCT-15

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 unspecified date in Sep-2015, a 17 year old, feline, of unspecified signalment, and 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?

Unknown

Subform III: Domestic Animal Incident Report

1. Source of Report

Other

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 )

17

7. Weight (provide a range if necessary )

Unknown

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

• General
  • Symptom - Death
  • Symptom - Dehydration

12. How long did the symptoms last?

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

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

No

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 2-Oct-2015, the cat exhibited dehydration and fleas and then died. It is unknown if a necropsy was performed. Due to the sensitive nature of the communication, specific relevant event details were not obtained, nor will such be sought. The reason for the initial mail contact was to discuss a product used on the dog and not to discuss the death of this cat. No further information is expected. 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

Dehydration and subsequent death are not expected after topical application of the product, as inconsistent with pharmaco-toxicological product profile. Product has wide margin of safety. Oral LD50 in rat 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effects. The cat likely died due to old age or dehydration. Additionally, the reason for the initial call to Bayer was to discuss a product used on the dog and was not to report the death of this patient. Considering this intent, it is reasonable to assume that the owner did not believe in product connection of any sort. SLEE is not evident as regular treatments for at least a 6-week period are necessary in order to break the flea development circle. Otherwise preexisting pupae may still emerge from the environment and re- infest the pet. Efficacy against fleas can be expected only after this period. Considering all aspects, even though time to onset and whether necropsy was performed are unknown, product relation is unlikely.