MalfunctionOMP
PREVENA¿ PEEL PLACE¿
Received May 27, 2026 · Event occurred Apr 20, 2026
Report 25299744 · MDR key 25299744
Device
Generic name
Negative Pressure Wound Therapy Powered Suction Pump
Manufacturer
Kci Usa, Inc.Model number
PRE1101USCatalog number
PRE1101US
Lot number
C23251V005
Patient
NA · Unknown
- Blister
Narrative
Description of Event or Problem
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.