Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3797

2. Registrant Information.

Registrant Reference Number: 2015CK282

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.

18-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 - small 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 18-Oct-2014, a (age) year old, 135 Pounds, woman, in fair condition, with thyroid nodules, placed a Seresto Small Dog (Flumethrin-Imidacloprid) collar around the neck of her canine.

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

3. List all symptoms, using the selections below.

System

• General
  • Symptom - Pain

• Nervous and Muscular Systems
  • Symptom - Seizure
  • Symptom - Unconsciousness
  • Symptom - Difficulty talking

• General
  • Symptom - Lethargy

• Unknown
  • Symptom - Other
  • Specify - thyroid gland disorder

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?

Unknown

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)

None

10. Route(s) of exposure.

Skin

11. What was the length of exposure?

Unknown / Inconnu

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.)

Approximately 2 hours following the placement of the collar, the individual developed pain under her left arm.On 21Oct2014, the individual had a seizure. The woman blacked out and could not speak for approximately 15 seconds.On 01Nov2014, the individual had a seizure. The individual presented to a neurologist for examination. No further diagnostics have been performed at this time.On 29Nov2014, the individual became lethargic.On 17Dec2014, the individual's thyroid nodules increased in size. The individual presented to the physician and a biopsy was performed. The results are unknown at this time.On 21Dec2014, the individual removed the Seresto Small dog collar from her dog.On 24Dec2014, the pain and lethargy improved, however are not resolved.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N - Unlikely. Pain in arm, seizure, black out, loss of speech and increse in thyroid nodules are not expected with topical product use, as inconsistent with pharmaco-toxicological product profile. Lethargy is likely a consequence reported seizure. The woman was in fair condition with thyroid nodules previous to product application. Though time to onset for pain in arm is short, other signs have occured long time after collar administration. Signs did not resolved completly after collar removal. Considering all aspects, a product relation is deemed to be unlikely. Initial assessment confirmed by medical doctor.