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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3238

2. Registrant Information.

Registrant Reference Number: 2013AM143

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.

13-JUN-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

18-JUL-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. 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).

One vial of Advantage II large cat 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

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?

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

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 - Stiffness
    • Specify - rear legs
    • Symptom - Difficulty walking
    • Symptom - Paralysis
  • Renal System
    • Symptom - Other
    • Specify - difficulty urinating
  • Cardiovascular System
    • Symptom - Stroke

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?

Yes

14. b) How long was the animal hospitalized?

Unknown

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

The owner applied the Advantage II for Large Cats to the cat on 7/18/11. On 7/19/11 the cat seemed stiff in the rear legs and was knucking over on the left front leg. The cat is currently at the veterinary clinic being examined, however no treatments have been done at this point. The veterinarian did say that the exact same thing occured last month 1 day after the application. The cat was treated with dexamethasone and radiographs were done with no significant findings. The cat recovered within 1 weeks time. 23.05.2012: On approximately 26 July 2011 the cat developed paralysis of all four legs and could not urinate on his own. The cat was hospitalized at the clinic daily and had his bladder expressed twice a day until 22 May 2012 when the cat seemed to have a stroke and pass away.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Originally reported signs -'Neurological signs NOS' and 'Stiff gait' are not typically observed with appropriate topical product administration. An appropriate dosage was applied and no oral product uptake reported. Update information concerning clinical course not reliable. Paralysis, stroke and finally fatal outcome 10 months after product application indicate other cause for signs. Overall, product relation considered unlikely.