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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3102

2. Registrant Information.

Registrant Reference Number: 2013AM102

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 77 Belfield Rd

City: Toronto

Prov / State: ON

Country: Canada

Postal Code: M9W 1G6

3. Select the appropriate subform(s) for the incident.

Domestic Animal

4. Date registrant was first informed of the incident.

22-APR-13

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 II (unknown size)

  • 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.

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).

One vial of Advantage unknown size was applied topically by the owner to one spot on the dorsal midline.

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

Siamese

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

13

7. Weight (provide a range if necessary )

9

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Nervous and Muscular Systems
    • Symptom - Ataxia
    • Symptom - Head tilt
  • Eye
    • Symptom - Discharge eye

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

On approximately 26Jan2013 a 13 year old, 9 pound, neutered, male, Siamese feline, in poor condition, with hyperthyroidism, and chronic upper respiratory issues, was administered 1 tube of an unspecified size of Advantage II (Imidacloprid-Pyriproxyfen) once topically by the owner. The patient had also been on methimazole for the hyperthyroidism, and prednisone and azithromycin for the chronic upper respiratory issues. The same day of application the patient developed ataxia, and a head tilt. The patient was seen by a veterinarian on 28Jan2013 and was also noted to have developed cloudy discharge coming from the his eyes. The patient was treated with subcutaneous fluids and an unspecified antibiotic eye ointment. 30Jan2013 the patient was seen again by a veterinarian. Signs seemed to have improved but not resolved. Radiographs were taken, however, there were no significant findings. The patient was then given maropitant-citrate. 20Feb2013 the patient was evaluated by a veterinarian and noted to have lost weight. The patient was treated with an unspecified homeopathic remedy. 22Feb2013 blood work was ran and found to be within normal limits, however, the patient was found positive for the corona virus. The patient was seen for a neurological consult at a specialty clinic on approximately 26Feb2013 and passed away.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Head tilt and ataxia are not typically observed with appropriate topical product administration. Although unknown dosage was applied and no oral product exposure reported, product was used before without causing signs. Compatible time to onset but duration of signs too long. Ocular discharge and weight loss more result of medical history with poor condition of elderly cat. Signs more likely related to underlying disease or infection and merely co-incidental with product application. Finally death not expected after product application, 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 effect. For early mild neurological signs product relation cannot be completely excluded. However, for other signs and fatal outcome involvement of Advantage considered unlikely. These signs and fatal outcome more likely related to pre-existing health history and concurrent infection of elderly cat.