MalfunctionEXB

FLEXTEND 1000ML FECAL CONTAINMENT DEVICE

Received Aug 15, 2019 · Event occurred Aug 5, 2019

Report 8896336 · MDR key 8896336

Device

Generic name

Collector, Ostomy

Manufacturer

Hollister Inc.

Model number

9880

Product problems

Adverse Event Without Identified Device or Use Problem

Patient

31025 DA

Skin Tears
Skin Tears

Narrative

Description of Event or Problem

PATIENT RECEIVED A SKIN TEAR TO THE COCCYX AREA WHEN THE DEVICE WAS REMOVED. ALL INSTRUCTIONS FOLLOWED. HOLLISTER FLEXTEND 1000 ML 9880 FECAL CONTAINMENT DEVICE.