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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3343

2. Registrant Information.

Registrant Reference Number: 2011CP029US0024279

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: K9advantix

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 8.8 %
    • PERMETHRIN
      • Guarantee/concentration 44 %

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 on a cat

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

Subform III: Domestic Animal Incident Report

1. Source of Report

Animal's Owner

2. Type of animal affected

Cat / Chat

3. Breed

domestic short hair

4. Number of animals affected

1

5. Sex

Unknown

6. Age (provide a range if necessary )

2

7. Weight (provide a range if necessary )

Unknown

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>3 days <=1 wk / >3 jours <=1 sem

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 - Muscle tremors
  • General
    • Symptom - Hyperthermia
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Loss of appetite
    • Specify - decreased appetite
  • Nervous and Muscular Systems
    • Symptom - Unresponsive
  • General
    • Symptom - Hypothermia
  • Liver
    • Symptom - Other
    • Specify - ALKP low

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?

12

Hour(s) / Heure(s)

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 an unknown size of the K9 Advantix to the cat on 6/20/11. On 6/21/11 the cat was found tremoring so the cat was brought to the veterinary clinic. The cat was tremoring and was hyperthermic on examination. The cat was given subcutaneous fluids, bathed with dish soap and had bloodwork done. The bloodwork was within normal limits, however the ALKP =6 (10- 16 normal range). The cat was released later that day because the cat was asymptomatic. On 6/22/11 the owner reported that the cat was still doing well, however she did have a decreased appetiteOn 6/23/11 the cat started having tremors again. On 6/24/11 the cat was found having tremors, very lethargic and non responsive. The cat was taken to the veterinary clinic where it was found to be hypothermic as well (96 deg F). The cat was put on intravenous fluids and intravenous methocarbamol. The cat ended up passing away on its own the evening of 6/24/11. A necropsy was not performed


To be determined by Registrant

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

Death

19. Provide supplemental information here

Tremoring possibly typical mild signs of intoxication after direct contact with permethrin. Hperthermia secondary to this. But subsequent chronological sequence and outcome very unusual. Cat released from clinic asymptomatic after washing and infusion. Cat showed severe signs two days later and died on following day inspite of treatment. No necropsy initiated. Either washing did not eliminate all product or other intercurrent health issue to be considered, as chronology so unusual