MAUDE Adverse Event Report: 3M COMPANY; RAZOR, SURGICAL

Model Number	9690
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
During pre-op prep of patient, clippers used and abrasion to skin noted at site after use.Md aware, site cleansed, no further intervention required.

• Common Device Name: RAZOR, SURGICAL
• Manufacturer (Section D): 3M COMPANY; 610 north county rd. 19; aberdeen SD 57401
• MDR Report Key: 8330675
• Report Number: 8330675
• Device Sequence Number: 10774881
• Product Code: LWK
• UDI-Device Identifier: 50707387575217
• UDI-Public: (01)50707387575217
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/07/2019
• Report Date (Section F): 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 9690
• Device Catalogue Number: 9690
• Device Lot Number: 20181111
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 02/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/07/2019