Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2331

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0021176 (Report 486386)

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

Address: 2920 Matheson BLVD

City: Mississaugua

Prov / State: ON

Country: Canada

Postal Code: L5W5R6

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

Human

4. Date registrant was first informed of the incident.

15-MAY-18

5. Location of incident.

Country: UNITED STATES

Prov / State: PENNSYLVANIA

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. 11556155

Product Name: Seresto collar

• Active Ingredient(s)
  • FLUMETHRIN
    • Guarantee/concentration 4.5 %
  • 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 2017, an x year old woman, in unknown condition, with concomitant medical conditions of pulmonary fibrosis, hyponatremia, milk allergy, a burning sensation on the left side of the face, left arm, left leg, partially on the tongue, and on the hands, and a cough, was exposed to an unknown amount of 1 Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar when she rinsed the powder off of the collar then applied it to her dog. She washed her hands with an unspecified soap after handling the collar and after each time she touched the dog.

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: >64 yrs / > 64 ans

3. List all symptoms, using the selections below.

System

• Gastrointestinal System
  • Symptom - Other
  • Specify - Digestive tract disorder NOS

• Respiratory System
  • Symptom - Coughing

• Blood
  • Symptom - Hyponatremia

• Respiratory System
  • Symptom - Other
  • Specify - Pulmonary fibrosis

• Skin
  • Symptom - Burning skin

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)

Application

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

Unknown

10. Route(s) of exposure.

Skin

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.)

On an unspecified date post exposure, in approximately Oct 2017, the individual was examined by a physician who determined she had gastroesophageal reflux disorder. The individual was examined by a gastrointerologist and an endoscopy was performed with unknown results. The clinical signs continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N - Unlikely Both direct and indirect exposure to the collar occurred. Affected site not compatible with exposed site. No oral exposure via contaminated hands reported. Furthermore the patient washed her hands repeatedly after each exposure. Reported gastroesophageal reflux disorder is not expected with appropriate product use as not consistent with product's pharmacological profile. Other causes are more likely. The involved geriatric patient had a history of various other health problems which may have contributed to the sign. Although time to onset unknown, considering known safety profile an product involvement is considered unlikely. Initial assessment confirmed by medical doctor.