Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0914

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0000289 (Report 466024)

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.

03-JAN-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. 11556-155

Product Name: Seresto Large dog collar

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

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PMRA Registration No.       PMRA Submission No.       EPA Registration No.

Product Name: Seresto Small dog collar

• Active Ingredient(s)
  • FLUMETHRIN
  • IMIDACLOPRID

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7. b) Type of formulation.

Other (specify)

COLLAR

Application Information

8. Product was applied?

Yes

9. Application Rate.

Unknown

10. Site pesticide was applied to (select all that apply).

Site: Other / Autre

Préciser le type: Exposed to 1 Seresto Large Dog collar while the dog slept with the owner each night.

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 May 2017, a age year old, woman, in unknown condition, with concomitant medical conditions of arthritis, osteoarthritis of the hand, carpal tunnel syndrome, a chronic renal disorder NOS, bile duct disorder NOS, gastric esophageal reflux disease (gastric irritation), heartburn, hypothyroidism, hypertension, osteoporosis (bone and joint disorder NOS), atrial fibrillation, pancreatic lesion (pancreas disorder), stenosing tenosynovitis/trigger finger (tendon injury), vitamin D deficiency, Fuchs corneal dystrophy (eye disorder NOS), corneal ulcer (corneal disorder NOS), diplopia esotropia (diplopia), posterior capsule opacification (eye disorder NOS), peripheral vascular disorder, anterior basement membrane dystrophy (eye disorder NOS) and abducens (6th) nerve palsy (cranial nerve disorder), was exposed to 1 Seresto Large Dog (Flumethrin-Imidacloprid) collar while the dog slept with her each night.

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

• Eye
  • Symptom - Double vision
  • Symptom - Other
  • Specify - One eye was unable to move (eye disorder NOS)

• Nervous and Muscular Systems
  • Symptom - Headache

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?

Yes

6. b) For how long?

3

Day(s) / Jour(s)

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)

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 2017, the individual experienced double vision. She was examined by multiple physicians (neurologist, primary care physician, prism eye doctor and a general eye doctor) and had multiple tests performed (MRI, fluorescein, various ocular tests, CT scan and bloodwork); no abnormalities found. On an unspecified date post exams, in approximately Jun 2017, the individual experienced headaches and one eye was unable to move (eye disorder NOS). She was examined by a physician, hospitalized for 3 days, and administered an unspecified dose of intravenous fluids. It was determined by physicians that the woman had an unspecified nerve palsy (cranial nerve disorder). On an unspecified date, in approximately 2017, the collar was removed from the dog. On an unspecified date, in approximately Oct 2017, the individual placed 1 Seresto Small Dog (Flumethrin-Imidacloprid) collar around the dog's neck. On an unspecified date post exposure to the Seresto Small Dog collar, in approximately 2017, the clinical signs worsened.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N-Unlikely: Indirect exposure occurred to the product as person slept with treated dog in the same bed. It is unclear whether affected sites are consistent with exposed site. Reported double vision, headache, unable to move and cranial nerve disorder are not expected after topical product application and are inconsistent with the pharmaco-toxicological product profile. The collar is odorless and its active ingredients not volatile at room temperature. Moreover, patient has concomitant history of eye disorder, cranial nerve disorder which may have contributed to signs. Other causes are more likely. Though time to onset is unknown considering concomitant history of this geriatric patient product relation is deemed to be unlikely. Initial assessment confirmed by medical doctor.