Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-2165

2. Registrant Information.

Registrant Reference Number: 2017KP109

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.

19-APR-17

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. 11556-127

Product Name: advantage II large dog

• 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.

2.5

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 Aug 2016, a 13 year old, 6 pound,neutered, female, Domestic Longhair feline, in unknown condition, with no known concomitant medical conditions, was administered a partial tube of Advantage II Large Dog(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 Longhair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

6

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

<=30 min / <=30 min

11. List all symptoms

System

• General
  • Symptom - Death

• Nervous and Muscular Systems
  • Symptom - Muscle tremors
  • Symptom - Ataxia

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

Immediately post application the cat developed tremors. The owner bathed with an unspecified dish soap. On an unknown date in Aug2016, 1 day post application, the tremors resolved. On an unspecified date in Nov2016 the cat developed ataxia. The cat was not examined by a veterinarian. On 15Nov2016 the cat died. No necropsy was performed. No further information is 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

Off-label use of product occurred as dog product was administered to cat. Reported tremor and ataxia are not expected with appropriate topical product use. No oral product exposure witnessed. Time to onset short for tremors and a rather behavioural response to the applied product cannot be fully ruled out, however time to onset too long for ataxia. 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 is 642 mg/kg BW. 24-fold overdosage tolerated by cats without showing any side effect. Animal involved in this case was geriatric, thus, other unrelated medical conditions may have contributed to the death of the animal. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time after death of the animal (almost after 3 months). Time to onset is too long for death. Even though some information is not available (animal health condition, medical history and necropsy report), considering known safety profile a product relation is considered unlikely.