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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1608

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0007401 (Report 473374)

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.

05-MAR-18

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: Advantage cat-unspecified

  • Active Ingredient(s)
    • Imidacloprid
      • Guarantee/concentration 9.1 %

7. b) Type of formulation.

Other (specify)

Spot-on

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

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 approximately 2012, a neutered, female, feline, of unknown age and weight, in unknown condition, with no known concomitant medical conditions, was administered 1 tube of Advantage (cat-unspecified) (Imidacloprid) 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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Unknown

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

Unknown

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

<=30 min / <=30 min

11. List all symptoms

System

  • General
    • Symptom - Death
    • Symptom - Lethargy
    • Symptom - Other
    • Specify - Diabetes

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

Approximately 1 minute post administration, the cat developed lethargy. Approximately 24 hours post administration, the lethargy resolved. On an unknown date post administration in approximately 2012, the cat developed diabetes. It was unknown if treatments or exams were performed. On an unknown date post administration in approximately 2012, the cat died. No 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 call was to discuss the use of the product in the owners current cats and not to report the death of the patient. No further information is expected. This case is closed.


To be determined by Registrant

18. Severity classification (if there is more than 1 possible classification

Death

19. Provide supplemental information here

N-Unlikely: Reported lethargy may be a behavioural response to the product sensation or to the product smell. Reported diabetes and death are not expected following appropriate topical product application as inconsistent with product's pharmacological profile. 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. In case of suspected product involvement, adverse event would have been reported in close proximity and not long time (6 years) after. Further, the owner did not believe in product involvement either as the reason for the initial call was to discuss the use of the product in the owner's current cats and not to report the death of the patient. Time to onset is consistent for initially reported lethargy but it is unknown for later reported adverse events. Despite of necropsy is not available, a product relation is consider as unlikely.