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Consumer Product Safety

Incident Report

Subform I: General Information

1. Report Type.

New incident report

Incident Report Number: 2018-0476

2. Registrant Information.

Registrant Reference Number: USA-BAYERBAH-2017-US0078889 (Report 465204)

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.

22-DEC-17

5. Location of incident.

Country: UNITED STATES

Prov / State: CALIFORNIA

6. Date incident was first observed.

22-SEP-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. 11556-152

Product Name: Advantage II Large Cat

  • Active Ingredient(s)
    • IMIDACLOPRID
      • Guarantee/concentration 9.1 %
    • PYRIPROXYFEN
      • Guarantee/concentration .46 %

7. b) Type of formulation.

Other (specify)

SPOT ON

Application Information

8. Product was applied?

No

9. Application Rate.

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

11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).

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: Unknown / Inconnu

3. List all symptoms, using the selections below.

System

  • Skin
    • Symptom - Pain

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?

No

6. b) For how long?

7. Exposure scenario

Non-occupational

8. How did exposure occur? (Select all that apply)

Pesticide Spill

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?

<=15 min / <=15 min

12. Time between exposure and onset of symptoms.

<=30 min / <=30 min

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 September 22 2017, a man , administered an unknown pain medication since approximately 2017, was exposed to an unknown amount of advantageII large cat, when he spilled the product on a fifth digit knuckle, on the left hand; immediately post exposure, the individual experienced pain at the exposure site; the individual washed his hands with an unspecified soap for 10 minutes, then applied isopropyl alcohol. On an unspecified date post exposure, in approximately 2017, the individual played the guitar and piano, after a few minutes the clinical sign worsened. The individual was not examined by a physician and the clinical sign continued.

To be determined by Registrant

14. Severity classification.

Major

15. Provide supplemental information here.

O - Unclassifiable/unassessableDirect product exposure occurred. Affected area compatible with exposed area. Time to onset short. Pain at exposure site is not typically seen however may be related to product exposure. However recurrence of sign and ongoing pain at exposure site is not expected, in particular not as the product was removed from the exposure site. The persons underlying condition requiring ongoing application of unspecified pain medication may play a role in recurrence of signs. Further chronology is unclear as duration of sign not described. No medical exam performed and thus no further information available. Due to limited information, a product relation is unassessable. Preliminary assessment. Pending the final assessment after evaluation by medical doctor. If assessment is changed, the final statement will be submitted.