MAUDE Adverse Event Report: KCI USA, INC. PREVENA¿ PEEL PLACE¿; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

Model Number	PRE1101US
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Defective battery.

• Brand Name: PREVENA¿ PEEL PLACE¿
• 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: 23815559
• Report Number: 23815559
• Device Sequence Number: 10104581
• Product Code: OMP
• UDI-Device Identifier: 00849554004627
• UDI-Public: (01)00849554004627
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 11/24/2025
• Report Date (Section F): 11/24/2025

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 Model Number: PRE1101US
• Device Lot Number: C22789V005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2025
• 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: 59 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Date Report Sent to FDA: 11/24/2025