MAUDE Adverse Event Report: CAREFUSION 2200, INC N/A SURGICAL CLIPPER; RAZOR, SURGICAL

Model Number	4406
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While preparing the patient for surgery, the shaver blade was found to be dull, causing the patient to have an abrasion to the area being prepped.

• Brand Name: N/A SURGICAL CLIPPER
• Common Device Name: RAZOR, SURGICAL
• Manufacturer (Section D): CAREFUSION 2200, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 20199184
• Report Number: 20199184
• Device Sequence Number: 6880250
• Product Code: LWK
• UDI-Device Identifier: 10885403473142
• UDI-Public: (01)10885403473142
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 04/26/2024
• Report Date (Section F): 04/26/2024

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: Health Professional
• Device Model Number: 4406
• Device Catalogue Number: 4406
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Date Report Sent to FDA: 04/26/2024