inforMED
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

PRE1101US

Catalog 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.