Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2015-3848

2. Registrant Information.

Registrant Reference Number: 2015CK275

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.

25-NOV-13

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. 1556-155

Product Name: Seresto Collar - large 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 approximately 22-Nov-2013, a (age) year old woman, who is allergic to dogs and cats, placed a Seresto Large Dog (Flumethrin-Imidacloprid) collar around the neck of her cat.

To be determined by Registrant

12. In your opinion, was the product used according to the label instructions?

No

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

• Skin
  • Symptom - Lesion

• Respiratory System
  • Symptom - Dyspnea

4. How long did the symptoms last?

>1 wk <=1 mo / > 1 sem < = 1 mois

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

Yes

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)

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.

>24 hrs <=3 days / >24 h <=3 jours

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 approximately 25-Nov-2013, the owner was bitten by the cat, developed dyspnea, went to urgent care and was treated with an unspecified antibiotic for an unspecified length of time.On 04-Dec-2013 signs of dyspnea appeared, nebulization was not effective at home or at the Emergency Room where an unspecified oral steroid was administered. The signs continue.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

N - Unlikely. Direct dermal product exposure may have occurred when applying collar, however no signs were seen for the next 3 days. Signs started after person was bitten by the cat. Cat bite has caused a lesion. Observed dyspnea may be the result of the persons known hypersensitivity to cats. A relation of the dyspnea with the collar is rather unlikely due to the inconsistent onset time and as no exposure to the collar was reported prior to onset of dyspnea. Even with collar exposure dyspnea would not be expected. If any, reactions would be expected at the exposure site (hands). Considering all aspects, a product relation is deemed to be unlikely. Initial assessment confirmed by medical doctor.