Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2011-3344

2. Registrant Information.

Registrant Reference Number: 2011CP030US0012212

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.

Human

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.

23-APR-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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. Unknown

Product Name: K9advantix 100

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

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7. b) Type of formulation.

Liquid

Application Information

8. Product was applied?

No

9. Application Rate.

10. Site pesticide was applied to (select all that apply).

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

To be determined by Registrant

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

Unknown

Subform II: Human Incident Report (A separate form for each person affected)

1. Source of Report.

Other

2. Demographic information of data subject

Sex: Male

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Bloating
  • Symptom - Diarrhea
  • Symptom - Vomiting

• General
  • Symptom - Lethargy

4. How long did the symptoms last?

Unknown / Inconnu

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

Yes

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Unknown

8. How did exposure occur? (Select all that apply)

Other

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

Unknown / Inconnu

13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)

Caller states that her dog was diagnosed with Lyme disease on 4/18/11. The product was applied to the dog on 4/19/11. Dog was on Animax ointment and oral Clavamox drops. On 4/23, her husband became lethargic and had vomiting, bloating and diarrhea. He was taken to ER on 4/26 and had test performed, and was admitted to hospital. He was diagnosed with c-dif (bacterial infection "caused from antibotics"). He was treated with IV fluids and medications (unknown exactly what) and released yesterday. Husband's symptoms have resolved. Caller believes that husband was exposed to the oral antibiotic that her dog was prescribed to, but is unsure how (perhaps the dog licked him after it was given the Clavamox drops). FU 2011-05-03: 5/3/2011 2:00:10 PM Anderson, Traci Cb: Spoke with [name]. She reports her husband has a bowel obstruction, not c-dif, as previously reported. He is under care with his health care provider. Case closed. No further information is expected. Case is closed.

To be determined by Registrant

14. Severity classification.

Moderate

15. Provide supplemental information here.

No direct or indirect exposure to product reported. Time between treatment of dog and onset of signs in patient too long for connection. Observed signs unspecific, and not expected as inconsistent with product's pharmacotoxicological profile. Doctor finally diagnosed patient with a bowel obstruction. Thus, relation with Advantix ruled out. Initial assessment confirmed by medical doctor. Follow-up reporting as further information was added.