MAUDE Adverse Event Report: KCI USA, INC. PREVENA RESTOR BELLAFORM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	PRE5355
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Upper middle-aged female with history of breast cancer.During surgery for right breast mastectomy, sentinel node bx and reconstruction the pump would not stay on to work.Another device obtained, no known harm to patient.

• Brand Name: PREVENA RESTOR BELLAFORM
• Common Device Name: NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
• Manufacturer (Section D): KCI USA, INC.; 12930 ih 10 west; san antonio TX 78249
• MDR Report Key: 10546285
• Report Number: 10546285
• Device Sequence Number: 14329457
• Product Code: OMP
• UDI-Device Identifier: 00849554007178
• UDI-Public: (01)00849554007178(17)210831(10)7202887V001
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/02/2020
• Report Date (Section F): 09/02/2020

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: PRE5355
• Device Lot Number: 7202887V001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 88
• Date Report Sent to FDA: 09/02/2020