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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-6383

2. Registrant Information.

Registrant Reference Number: 2013CK049

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.

21-OCT-13

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

09-SEP-13

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).

On 08-Sep-2013, a 21 year old, 12 pound, spayed female, Domestic Mediumhair feline, in good condition, with a current flea infestation, was administered 1 tube of Advantage II Large Cat (Imidacloprid-Pyriproxyfen) once topically by the owner.

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

Domestic Medium Hair

4. Number of animals affected

1

5. Sex

Female

6. Age (provide a range if necessary )

21

7. Weight (provide a range if necessary )

12

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

>1 wk <=1 mo / > 1 sem < = 1 mois

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Skin
    • Symptom - Dry skin
  • General
    • Symptom - Lethargy
  • Gastrointestinal System
    • Symptom - Weight loss
  • Respiratory System
    • Symptom - Dyspnea

12. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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 09 Sept 2013 the cat developed lethargy, dyspnea and seborrhea sicca. The cat was eating and drinking. On approximately 13 Sept the cat appeared to be losing weight. On 16 Sept 2013 the cat 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

Although sign is rather unspecific, lethargy may exceptionally occur in particular sensitive animals. Dyspnea, seborrhea sicca, losing weight and death are not anticipated with topical product exposure 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. Short time to onset but duration of signs too long. No vet consulted. Other underlying causes for death in this geriatric cat related to dyspnea, weight loss and old age more likely. Therefore a product relation is considered unlikely.