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

Model Number	PRE1101US
Health Effect - Clinical Code	Blister (4537)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple caregivers reported that the prevena incision management system frequently had quality issues.Reported issues were blistering patient skin on removal, difficult to use, not sealing properly, and having to be changed more frequently than the previous brand used by the hospital.All surgeons independently stopped using the dressings.They have been replaced with another brand that is of a better quality.

• 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: 25299744
• Report Number: 25299744
• Device Sequence Number: 9319080
• Product Code: OMP
• UDI-Device Identifier: 00849554004627
• UDI-Public: (01)00849554004627(17)280630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/22/2026
• Report Date (Section F): 04/22/2026

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 Catalogue Number: PRE1101US
• Device Lot Number: C23251V005
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/27/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/27/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/22/2026