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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2013-3233

2. Registrant Information.

Registrant Reference Number: 2013AM138

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.

22-MAY-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

Domestic shorthair

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

7

7. Weight (provide a range if necessary )

10

lbs

8. Route(s) of exposure

Skin

9. What was the length of exposure?

Unknown / Inconnu

10. Time between exposure and onset of symptoms

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

11. List all symptoms

System

  • General
    • Symptom - Death
  • Cardiovascular System
    • Symptom - Cardiac arrest
  • Skin
    • Symptom - Jaundice
  • General
    • Symptom - Other
    • Specify - organ function failure
  • Blood
    • Symptom - Other
    • Specify - low lymphocytes
    • Symptom - Other
    • Specify - high granularcyte
    • Symptom - Other
    • Specify - HCT (hematocryte) high
    • Symptom - Other
    • Specify - MCH (mean corpuscular hemoglobin) low
    • Symptom - Thrombocytopenia
    • Symptom - Abnormal coagulation
    • Specify - ALP low (alkaline phosphatase)
    • Symptom - Other
    • Specify - ALT high (alanine aminotransferaset)
    • Symptom - Other
    • Specify - high bilirubin (TBIL high)
    • Symptom - Blood urea nitrogen increased
    • Symptom - Hypercalcemia
    • Symptom - Hyperphosphatemia
    • Symptom - Other
    • Specify - GLU low (glucose)
    • Symptom - Other
    • Specify - TP high (total protein)
    • Symptom - Abnormal coagulation
    • Specify - GLOB high (globulin)

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?

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 12May2011 owner applied monthly dose of Advantage II Large to Slim a 7 year old neutered male Domestic Short hair that weighs 10 pounds. On 22May2011 this feline collapsed. On 23May2011 the doctor examined and found this feline was very jaundice. This feline went in to cardiac arrest and passed away while the veterinarian was obtaining blood for testing. Blood work showed full organ function failure. Resutls were: Lymphcytes % low at 7.5% (12-45), Granularcyte % High at 86 (35-80), RBC High at 11.71 (4.6-10), HCT high at 50.8 % (28- 49), MCH low at 12..4 pg (13-21), MCHC low at 28.7 g/dL (30-38), PLT low at 92 (100-514), ALP low 5 (10-90), ALT High 205 (20-100), TBIL High 10.8 (0.1-0.6), BUN High 82 (10-30), CA High 11.9 (8.0-11.8), PHOS High 11.2 (3.4-8.5), Glu low 57 (70- 150), TP High 9.4 (5.4-8.2), and GLOB High 6.0 (1.5-5.7) No necropsy was preformed.


To be determined by Registrant

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

Death

19. Provide supplemental information here

Signs are not anticipated with appropriate product administration as inconsistent with the product`s pharmacological profile. Onset time of 10 days is a too long timeframe for a product connection as well. The product was used on this cat in the past without causing any signs. Onset of signs was due to other underlying medical conditions as demonstrated by abnormal blood values. Finally, a product connection was ruled out.