Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2014-6091

2. Registrant Information.

Registrant Reference Number: 2014CK378

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.

20-OCT-14

5. Location of incident.

Country: UNITED STATES

Prov / State: UNKNOWN

6. Date incident was first observed.

25-AUG-14

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-151

Product Name: Advantage II small cat

• Active Ingredient(s)
  • IMIDACLOPRID
    • Guarantee/concentration 9.1 %
  • PYRIPROXYFEN
    • Guarantee/concentration .46 %

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

Yes

9. Application Rate.

.4

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 24Aug2014, a 6 month old, 5.00 pound, intact, male, Domestic Longhair feline, in good condition, with no known concomitant medical conditions, was administered 1 tube of Advantage II Small Cat (Imidacloprid-Pyriproxyfen) topically by the owner

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

dlh

4. Number of animals affected

1

5. Sex

Male

6. Age (provide a range if necessary )

0.5

7. Weight (provide a range if necessary )

5

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

• Gastrointestinal System
  • Symptom - Vomiting

• Nervous and Muscular Systems
  • Symptom - Recumbent

• General
  • Symptom - Hypothermia

• Respiratory System
  • Symptom - Tachypnea

• General
  • Symptom - Lethargy
  • Symptom - Adipsia

12. How long did the symptoms last?

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

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

No

14. a) Was the animal hospitalized?

No

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 25Aug2014 the cat began to vomit, was lethargic and adipsic. The cat was bathed in an unknown shampoo.On 26Aug2014 the cat was examined by a veterinarian. Upon presentation the cat continued to be lethargic, was lateral and hypothermic (99.5 F). He had a normal heart rate at 210 bpm but an increased respiratory rate at 44. It is unknown what treatments, if any, were performed.On 27Aug2014 the cat was taken to an emergency veterinarian clinic where he recevied an unknown amount of injectable dexamethasone and subcutaneous fluids.Approximately 8 hours later the cat passed away from an unknown cause.

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To be determined by Registrant

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

Death

19. Provide supplemental information here

Lethargy is an unspecific sign and may have multiple potential other causes in an animal. The other reported clinical signs (such as vomiting, adipsia, laterally recumbent, hypothermia and increased respiratory rate) are not anticipated with appropriate topical product use. Oral ingestion of product was not observed. Even with oral product exposure signs would not be expected, but rather salivation. Signs are unspecific and may have various other causes. Similarly, death 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. Other causes are more likely in a young cat with multiple disorders. No necropsy was performed. Finally, a connection with the product was considered to be unlikely.