Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-2324

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0019745 (Report 484897)

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.

10-MAY-18

5. Location of incident.

Country: UNITED STATES

Prov / State: ALABAMA

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.

10

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 2016, an x old, woman, in unknown condition, with concomitant medical conditions of hypertension, fibromyalgia and allergies to statin drugs and gabapentin, was exposed to an unknown amount of Seresto Dog (unspecified) (Flumethrin-Imidacloprid) collar and an unknown amount of Seresto Cat (Flumethrin-Imidacloprid) collars when she applied them to her 1 dog and 9 cats without wearing gloves.

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

• Nervous and Muscular Systems
  • Symptom - Other
  • Specify - Tingling sensation
  • Symptom - Paresis
  • Symptom - Other
  • Specify - Limb weakness

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

Contact with treated area

What was the activity? when she applied them to her 1 dog and 9 cats without wearing gloves.

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 in approximately Jun-2016, the individual experienced a tingling sensation to the entire body, the sensation of the right side of the body being asleep and difficulty using the right arm and right hand. On unspecified dates in approximately 2016, post exposure, the individual was examined by multiple physicians who performed unspecified blood work, unspecified radiographs, an unspecified magnetic resonance imaging and other unspecified diagnostics, the results of which are all unknown. The individual continued to be exposed the collars on unspecified dates when she changed the collars on all the pets approximately every 8 months and the symptoms continued unchanged.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N - Unlikely Direct product exposure occurred when the lady applied the collars to her animals. Reported neurological signs are not expected with appropriate product use as inconsistent with product's pharmacological profile. Tingling sensation on the entire body is not expected as affected site not in line with usually exposed sites (hands, arms). No information about indirect exposure of affected site via contaminated hands. Signs may be due to concomitant medical conditions. Difficulty using the right arm and right hand may be attributed to neurological signs. The patient is geriatric as well. Furthermore signs would have been reported in close proximity to product application and not long time after (2 years). Even though time to onset is unknown, considering known safety profile an overall product involvement is unlikely. Initial assessment confirmed by medical doctor.