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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2012-3527

2. Registrant Information.

Registrant Reference Number: 2012BS011-US0002576

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.

18-APR-12

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

28-JAN-12

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).

On January 28th, 2012, 1 tube of Advantage unspecified size, was applied topically to a 7 year old, 14 lb Ragdoll Feline in good condition.

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

Ragdoll

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

14

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>24 hrs <=3 days / >24 h <=3 jours

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • Nervous and Muscular Systems
    • Symptom - Paralysis
  • General
    • Symptom - Vocalizing
    • Symptom - Death

12. How long did the symptoms last?

>24 hrs <=3 days / >24 h <=3 jours

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 January 29th, 2012 the cat developed hind leg paralysis and was vocalizing. Cat was taken back to wildlife rescue facility where is was given an unknown amount of an injectable medication (route unknown). Cat was never seen by a veterinarian. On the morning of January 30th, 2012 the cat died and no necropsy was performed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Unlikely product related as reported clinical signs are inconsistent with pharmacological-toxicological product profile and experience. No signs of allergic/anaphylactic reaction. Cat from wildlife facility thus medical history and pre-existing diseases unknown. Product connection is unlikely rather related to underlying disease. Application and occurrence of signs most likely coincidental.