MalfunctionFMP

WAFFLE CUSHION

Received Jan 6, 2025 · Event occurred Nov 20, 2024

Report 21079059 · MDR key 21079059

Device

Generic name

Pressure Reduction Cushion

Manufacturer

Ehob, Inc.

Catalog number

220WC

Lot number

428122B

Patient

64 YR · Female

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NURSE TOOK WAFFLE CUSHION TAKEN OUT OF PACKAGING TO USE FOR PATIENT AND WAFFLE CUSHION WAS DEFLATED. ANOTHER CUSHION OBTAINED WITHOUT ISSUE. MANUFACTURER RESPONSE FOR PRESSURE REDUCTION CUSHION, WAFFLE CUSHION (PER SITE REPORTER). EQUIPMENT FAILURE REPORTED TO (RETRACTED EMAIL ADDRESS) ON (RETRACTED DATE). PRODUCT AVAILABLE FOR RETURN TO MANUFACTURER WITH MAILING LABELS PROVIDED BY MANUFACTURER. EQUIPMENT RETURNED TO MANUFACTURER ON (RETRACTED DATE) VIA UPS GROUND (RETRACTED TRACKING NUMBER).