Medline MSC50023Recalls & reported problems
Medline Industries, Inc. · WEDGE,FOAM,30 DEGREE,COVERED,NONSLIP,6PR · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277327726), received between Jul 17, 2024 and Aug 9, 2024 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Tissue Breakdown2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 9, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY THE PATIENT WAS FOUND "WITH AREA OF PARTIAL THICKNESS EROSION WITH SURROUNDING NON BLEACHABLE PURPLE DISCOLORATION OVER THE MIDTHORACIC VERTEBRAL PROCESS, PRESENTATION CONSISTENT WITH DEEP TISSUE INJURY."
Patient problems: Tissue Breakdown
MAUDE report 19949314 ↗InjuryJul 17, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY "DURING THE TRIAL PERIOD" THE PATIENT EXPERIENCED A STAGE II PRESSURE INJURY DESCRIBED AS "PINK WOUND BED WITH SMALL AREA OF DARKER DISCOLORATION" IN RELATION TO USING A 30-DEGREE NONSLIP FOAM WEDGE.
Patient problems: Tissue Breakdown
MAUDE report 19767013 ↗
Other SUPPORT, PATIENT POSITION devices
- ALLEN 103001Hill-Rom, Inc. · SUPPORT, PATIENT POSITION1 recall17 reports
- DeRoyal 8000HDPDeroyal Industries, Inc. · SUPPORT, PATIENT POSITION16 reports
- PILLOW, GENTLETOUCH, 7 INCH RT 1937Mizuho Orthopedic Systems, Inc. · Support, Patient Position11 reports
- Battalion 27428Alphatec Spine, Inc. · SUPPORT, PATIENT POSITION3 reports
- MEDLINE NON081147Medline Industries, Inc. · SUPPORT, PATIENT POSITION2 reports
- ACUFEX 72205103Smith & Nephew, Inc. · SUPPORT, PATIENT POSITION2 reports
- Berkette Beach Chair Limb Positioner 711200Aspen Surgical Products, Inc. · SUPPORT, PATIENT POSITION2 reports
- Olympic Vac-Pac Size 30Natus Medical Incorporated · Support, Patient Position2 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.