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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2017-0675

2. Registrant Information.

Registrant Reference Number: 2017KP031

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.

27-JAN-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)

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 %

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 approximately 01Sep2016, a 3 year old, unknown weight,neutered, male, Domestic Longhair feline, in unknown condition, with a concomitant medical condition of fleas, was started on a monthly application of 1 tube of Advantage II Large Cat (10% Imidacloprid +0.46% Pyriproxifen) 0.8 mL topically by the owner with the last dose being applied on01Nov2016.

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

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

Domestic Longhair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

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

Unknown / Inconnu

11. List all symptoms

System

  • General
    • Symptom - Death
  • Gastrointestinal System
    • Symptom - Diarrhea
    • Symptom - Anorexia
  • Respiratory System
    • Symptom - Other
    • Specify - Respiratory depression
  • General
    • Symptom - Jaundice
  • Gastrointestinal System
    • Symptom - Vomiting

12. How long did the symptoms last?

Unknown / Inconnu

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 an unspecified date in Nov2016, the cat was diagnosed with ear mites. 06Dec2016, the feline, with concomitant medical conditions of fleas and ear mites, was administered 1 tube of Advantage Multi for Cats (10% imidacloprid + 1% moxidectin) Topical Solution (Imidacloprid and Moxidectin) 0.8 mL topically by the owner. On 07-Dec-2016, the cat developed diarrhea, vomiting and anorexia. On 18-Dec-2016, the cat developed respiratory depression. The cat died on the way to the veterinary hospital. On exam, the veterinarian confirmed that the cat was dead and noted the jaundiced condition of the animal and the extreme amount of flea dirt. No further information is possible.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Vomiting and diarrhea are unspecific signs and may have many potential causes. Oral ingestion of product was not observed. Even with oral product exposure sign would not be expected, but rather salivation. Anorexia might be a consequence of reported digestive signs. Later reported respiratory depression, jaundice and death are not expected after product application, as they are inconsistent with pharmaco-toxicological product 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. In this case cat might have died due to ongoing medical condition. Considering over all too long time to onset, a product relation is deemed to be unlikely.