Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3795

2. Registrant Information.

Registrant Reference Number: 2015CK280

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.

10-OCT-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. 11556-155

Product Name: Seresto Collar - Large Dog

• 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 10-Oct-2014, a (age) year old, male, in good condition, with hypertension, placed one Seresto Large Dog (Flumethrin- Imidacloprid) collar around the neck of a canine.

To be determined by Registrant

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

Yes

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Respiratory System
  • Symptom - Difficulty Breathing
  • Symptom - Other
  • Specify - throat constriction
  • Symptom - Irritated throat

• Nervous and Muscular Systems
  • Symptom - Paresis
  • Specify - weakness in his leags

4. How long did the symptoms last?

Unknown / Inconnu

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

No

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 h

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.)

Approximately eight hours following collar placement, the individual developed constriction of his larynx and had difficulty breathing for approximately one minute. Following the episode the individual developed throat irritation;he has not been examined by a medical professional at this time.Follow-up received on 22nd of Oct, 2014: On 10-Oct-2014, a (age) year old, male, in good condition, with hypertension, placed one Seresto Large Dog (Flumethrin- Imidacloprid) collar around the neck of a canine. Approximately eight hours following collar placement, the individual developed constriction of his larynx and had difficulty breathing for approximately one minute. During this time the individual developed weakness in his legs. Following the episode the individual developed throat irritation;he had not been examined by a medical professional.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

O - Unclassifiable/unassessable. Unclear whether direct or indirect product exposure has occured. Respiratory tract disorders (constriction of larynx, difficulty in breathing and throat irritation) are not expected with appropriate collar use. The collar is odorless. Thus, disturbance by the collars smell is rather unlikely. No oral exposure via contaminated hands reported. Patient with underlying condition of hypertension that may have contributed to signs seen. Limb weakness is also unspecific and not expected after product use. Though time to onset is quite short, considering all aspects, a product connection remains unassessable.Initial assessment/causality confirmed by medical doctor.