MAUDE Adverse Event Report: Medline Industries LP Medline; WEDGE,FOAM,30DG,CVER,HANDLES,NONSLIP,6PR

Catalog Number	MSC50026
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Pressure Sore/Ulcer (2326); Tissue Breakdown (2681)
Date of Event	05/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
"top wedge removed blistered area identified near bottom corner of wedge was resting on right buttock".
Additional Manufacturer Narrative
It was reported that "top wedge removed blistered area identified near bottom corner of wedge was resting on right buttock".A stage two pressure injury was reported that required wound care.It has been determined that the reported event caused or contributed to a serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.

• Brand Name: Medline
• Common Device Name: WEDGE,FOAM,30DG,CVER,HANDLES,NONSLIP,6PR
• Manufacturer (Section D): Medline Industries LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 50175600
• Report Number: 1417592-2026-08382
• Device Sequence Number: 15961342
• Product Code: FMP
• UDI-Device Identifier: 10197344100392
• UDI-Public: 10197344100392
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: MSC50026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 181 LB
• Patient Race: White