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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-1610

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2018-US0007717 (Report 473723)

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-MAR-18

5. Location of incident.

Country: UNITED STATES

Prov / State: IOWA

6. Date incident was first observed.

25-DEC-17

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)

PMRA Registration No.       PMRA Submission No.       EPA Registration No. 11556-155

Product Name: Seresto collar

  • Active Ingredient(s)
    • FLUMETHRIN
      • Guarantee/concentration 4.5 %
    • IMIDACLOPRID
      • Guarantee/concentration 10 %

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 25-Dec-2017, a X year old, man, in unknown condition, with no known concomitant medical conditions, was secondarily exposed to an unknown amount of 1 Seresto (unspecified) (Flumethrin-Imidacloprid) collar when he was in the home with his parent's dog who was wearing the Seresto collar that was placed around the dog's neck on an unspecified date in approximately 2017. It was unknown if direct contact occurred with the collar or the dog or if the collar was applied correctly to the dog.

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: Male

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

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Pruritus
    • Symptom - Hives

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)

9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)

10. Route(s) of exposure.

Unknown

11. What was the length of exposure?

Unknown / Inconnu

12. Time between exposure and onset of symptoms.

>2 hrs <=8 hrs / > 2 h < = 8 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 4 hours post exposure, the individual experienced generalized pruritus and hives on both arms. The individual left the dog's residence and the clinical signs improved, but continued. On an unspecified date post onset, in approximately 2018, the hives on both arms resolved. The individual was not examined by a physician and the generalized pruritus continued intermittently.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

O - Unclassifiable/unassessable - Neither direct nor indirect exposure to product reported. Person was just in the same house with the treated pet. Individual had experienced generalized pruritus which is not expected. Usually hands, arms would be affected. No information about indirect exposure of affected site via contaminated hands. Hypersensitivity reactions such as hives to the collar are not typically seen although may occur with direct product exposure and respective disposition. Though time to onset short considering unclear exposure, a product involvement is unassessable.