Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-3234

2. Registrant Information.

Registrant Reference Number: US-BAYERBAH-2017-405843

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.

01-JUN-17

5. Location of incident.

Country: UNITED STATES

Prov / State: FLORIDA

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. 11556-151

Product Name: advantage II small 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 solution

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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).

An 18 year old, male feline, who had concomitant flea allergies, was administered one tube of Advantage II Small Cat 0.4 ml (Imidacloprid-Pyriproxyfen) topically by the owner. Weight is unknown.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

18

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

Unknown / Inconnu

11. List all symptoms

System

• General
  • Symptom - Death

12. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

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

2016-06-06 12:54:34 by Z, A : Call notes:The owner did mention a previous cat who did have a flea allergies who has since died at 18 yrs old. The animal was evaluated at the veterinarian at an unknown time, and the animal was taken home where he died. She had used the product on this animal and I was unable to determine when she placed it before the cat died, or even if she placed the product. No known necropsy was performed. Event Narrative: On an unknown date in 2016, an 18 year old, male feline, who had concomitant flea allergies, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner. On an unknown date in 2016, the cat was evaluated by the veterinarian, then died at home. No k nown necropsy was performed. Reason for use of drug: Adverse Reaction-Other Reproductive status: Unknown Case status: Closed Concomitant medications: UNK No more information is expected. The case is closed [Contact categorisation: Owner / Producer / Employee]

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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 Death is not expected following appropriate topical product application as inconsistent with products pharmacological profile. 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. Further, animal involved in this case was geriatric which may be the likely cause of death reported. Finally even though some information is not available (animal details, health condition, time to onset and necropsy report), considering the known product profile sufficient information exists to rule out product relation completely. Considering all aspects, a product involvement is unlikely.