Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2019-5923

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2019-US0053567 (Report 596445)

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.

07-SEP-19

5. Location of incident.

Country: UNITED STATES

Prov / State: OHIO

6. Date incident was first observed.

05-SEP-19

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?

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.

Data Subject

2. Demographic information of data subject

Sex: Female

Age: >19 <=64 yrs / >19 <=64 ans

3. List all symptoms, using the selections below.

System

• Nervous and Muscular Systems
  • Symptom - Numbness
  • Symptom - Other
  • Specify - Central nervous system disorder NOS
  • Symptom - Other
  • Specify - Brain disorder NOS

4. How long did the symptoms last?

Unknown / Inconnu

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

Unknown

6. a) Was the person hospitalized?

Yes

6. b) For how long?

Unknown

7. Exposure scenario

Non-occupational

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.

Skin

11. What was the length of exposure?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

>30 min <=2 hrs / >30 min <=2 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.)

On 05-Sep-2019, a x year old, woman, in unknown condition, with a concomitant medical condition of endometriosis, was accidentally exposed to an unknown amount of a Seresto (unspecified) (Flumethrin-Imidacloprid) collar while she held it in an unspecified hand for 15 minutes. Approximately 1 hour post exposure, the individual experienced a numb sensation in an unspecified hand at the exposure site. Approximately 4 hours post onset, the numb sensation worsened and she experienced numbness in an unspecified arm. On approximately 07-Sep-2019, the clinical sign worsened and she experienced numbness in her back. She was examined by a physician, hospitalized and magnetic resonance imaging was performed. Lesions were noted on the spine and brain. The physician believes that this is most likely hereditary multiple sclerosis as the patients sister also has multiple sclerosis. The physician plans on performing a second MRI to confirm this. No known treatments were performed and the clinical signs continued. Follow up 09-Sep-2019: Patient is still hospitalized, but the product has been ruled out as the cause. Per an MRI, lesions were found on her brain and spine, and doctor's now believe she most likely has hereditary multiple sclerosis. Physicians will be completing a second MRI to confirm. Caller notes that her daughter-in-law's sister also has multiple sclerosis. The physician believes that this is most likely hereditary multiple sclerosis as the patients sister also has multiple sclerosis. The physician plans on performing a second MRI to confirm this. No known treatments were performed and the clinical signs continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

[MAH (GDS)] O - Unclassifiable/unassessable - The individual was exposed to collar when she hold it in her hand. Reported application site numbness and time to onset are consistent with dermal exposure to collar. Product information states that user should wash their hands with cold water after fitting of collar. Reported numbness to arm and back, lesions on the spine and brain as well as continuation of signs are not expected and not consistent with the products pharmaco-toxicological profile. Time to onset is long. Other causes must be considered: The physician believes that this is most likely hereditary multiple sclerosis as the patients sister also has multiple sclerosis and ruled out the product as cause. Overall, considering all aspects, a product relation is unassessable. Preliminary assessment. Pending the final assessment after evaluation by medical doctor. If assessment is changed, the final statement will be submitted. [Human Medical Assessment] O - Unclassifiable/unassessable Unassessable as numbness could be the result of product exposure or a symptom of underlying hereditary multiple sclerosis. Initial numbness may be due to product exposure, though worsening over days in not unlikely.