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

Model Number PRE5355

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/28/2020

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 207319310
• Report Number: 10546285
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554007178
• UDI-Public: (01)00849554007178(17)210831(10)7202887V001
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: PRE5355
• Device Lot Number: 7202887V001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA
• Patient Weight: 88