MalfunctionOMP

PREVENA¿ PEEL PLACE¿

Received May 5, 2026 · Event occurred Mar 23, 2026

Report 25080978 · MDR key 25080978

Device

Generic name

Negative Pressure Wound Therapy Powered Suction Pump

Manufacturer

Kci Usa, Inc.

Model number

PRE1001US

Catalog number

PRE1001US

Lot number

C23638

Patient

NA · Male

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

PEVENA MACHINE MALFUNCTIONED - IT IS SUPPOSED TO CREATE SUCTION AND IT WOULD NOT KEEP A SEAL. MANUFACTURER RESPONSE FOR DRESSING, PREVENA (PER SITE REPORTER). IT WILL BE RETRIEVED AND QUALITY ANALYSIS WILL BE PERFORMED.