Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3796

2. Registrant Information.

Registrant Reference Number: 2015CK281

Registrant Name (Full Legal Name no abbreviations): Bayer Inc

Address: 2920 Matheson Boulevard

City: Missisaugua

Prov / State: ON

Country: Canada

Postal Code: L4W 5R6

3. Select the appropriate subform(s) for the incident.

Human

4. Date registrant was first informed of the incident.

05-AUG-15

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)

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PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto Collar - unknown

• Active Ingredient(s)
  • Flumethrin
  • IMIDACLOPRID
    • Guarantee/concentration 10 %

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7. b) Type of formulation.

Other (specify)

Collar

Application Information

8. Product was applied?

Yes

9. Application Rate.

1

Other Units: collar

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 an unspecified date in approximately Nov-2014, a woman of unknown age, weight, and reproductive status, in unknown condition with a concomitant medical conditions of unspecified allergies, applied a topical lotion to her hands and arms, applied medical gloves and was exposed to a Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar while removing it prior to bathing a client's dog with an unknown shampoo

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: Female

Age: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

• Skin
  • Symptom - Tingling skin

• Respiratory System
  • Symptom - Difficulty Breathing

• Nervous and Muscular Systems
  • Symptom - Dizziness

• Respiratory System
  • Symptom - Wheezing

• Gastrointestinal System
  • Symptom - Nausea

• Cardiovascular System
  • Symptom - Abnormally fast heart rate
  • Symptom - Chest tightness

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?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

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

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

Chemical resistant gloves

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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.)

Immediately after product exposure, the groomer's hands, face, and lips began tingling. She washed with soap and water.Approximately 45 minutes post product exposure, she experienced shortness of breath, tightness in her chest, dizziness, wheezing, nausea, and had a rapid pulse.Approximately 24 hours post collar exposure, she was examined by her medical doctor and treated with an unspecified dosage of prednisone.As of 25Nov2014, the symptoms continued unchanged and the prednisone was continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

O - Unclassifiable/unassessable. Unclear if direct or indirect exposure to collar occurred as case description clearly states that person wore gloves. Reported tingling sensation is not expected without direct product exposure. Not described that affected sites of face and lips were directly exposed to collar and also no indirect product exposure described. Usually, hands or arms would be affected, however with medical gloves no direct exposure to hands was possible. Other reported signs such as shortness of breath, tightness in chest, dizziness, wheezing, nausea, and rapid pulse are not expected as not in line with pharmaco-toxicological product profile. Other products were used concurrently, e.g. skin lotion, shampoo) and may have contributed to signs as well. Onset time reported to be short, though. Considering the provided data, a product involvement remains unassessable.