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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-4527

2. Registrant Information.

Registrant Reference Number: 2013AM206

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-AUG-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. 11556-152

Product Name: Advantage II Large Cat

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

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

Domestic shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

3

7. Weight (provide a range if necessary )

12

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 - Paralysis
  • General
    • Symptom - Vocalizing
  • Nervous and Muscular Systems
    • Symptom - Muscle tremors
    • Specify - head tremors
  • General
    • Symptom - Other
    • Specify - tongue hanging out
  • Nervous and Muscular Systems
    • Symptom - Convulsions
    • Symptom - Stiffness

12. How long did the symptoms last?

Unknown / Inconnu

13. Was medical treatment provided? Provide details in question 17.

Unknown

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

On 01Jun2013, a 3 year old, 12 pound, neutered, male, Domestic Shorthair feline, in good condition, who was lethargic, and had an active flea infestation, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) once topically by the owner. The patient had just finished a 7 day course of amoxicillin and clavulanic acid. The last dose had been given on 30May2013. 02Jun2013 the patient became paralyzed. The patient was bathed with dish soap and taken to be evaluated by a veterinarian. Upon exam the patient was noted to be blind. Blood work was performed and was within normal limits. No treatments were performed and the patient was sent home. 03Jun2013 the patient began vocalizing, developed head tremors, and his tongue was constantly hanging out. He then had a convulsion, became stiff, and passed away. 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

Intended direct topical dermal exposure of the product to the cat. Exposed site is inconsistent with affected site. Blindness and paralysis resulting in sudden death within short onset time is 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. Cause of signs due to underlying disease more likely, in particular as cat showed signs (lethargy) prior to product use and received antibiotic treatment for unknown medical problems. Considering this, a product relation is considered unlikely.