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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3337

2. Registrant Information.

Registrant Reference Number: 2011CP023US0025287

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.

15-JUL-11

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

21-JUN-11

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

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

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 tube was applied to the animal

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

Unknown

6. Age (provide a range if necessary )

.8

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

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

11. List all symptoms

System

  • Blood
    • Symptom - Anemia
  • General
    • Symptom - Lethargy
  • Respiratory System
    • Symptom - Dyspnea
  • General
    • Symptom - Death
    • Symptom - Weakness

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?

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

Caller does not have product to provide ID or Lot# Caller states he applied the product to his cat approx 1 week ago. The cat developed lethargy and weakness within 24 hours. The cat was taken to the DVM on 6/21/11 and blood work showed anemia. The cat was Rx'd Prednisone 5mg (tapering dose) to 'suppress the immune system' as well as Azithromycin suspension (1ml PO QD for 7-10), Multi - Vitamin Drop (0.5ml PO TID). The caller states he read online that Azithromycin was not helpful for anemia and the cat was re-evaluated by a different veterinarian for a second option as the cat was recommended to have a blood transfusion but the first vet did not have the ability to do this. The second vet performed the blood transfusion, and commenced Baytril on 6/25/11. The cat passed away on 6/27/11 at home after developing difficulty breathing and further weakness. The caller states he had an appointment at LSU later that day, that he didn't make, as the cat passed away while he was loading her into the car.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Patient had developed serious clinical signs prior to start of product. Even though no necropsy performed and other information (e.g. pipette size used) missing, neither severe blood and lymphatic disorders nor respiratory disorders or fatal outcome fit with toxicological product profile, even if overdose would have been applied. Most likely cat died due to underlying medical problems, e.g. anaemia (mycoplasma hemolytica suspected