MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SLING,FULL BODY MESH WITH COMMODE,MEDIU

Catalog Number	MDSMR114
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Codes	Localized Skin Lesion (4542); Skin Inflammation/ Irritation (4545)
Date of Event	01/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that ¿by the seam around the opening has become very irritating to the skin as well as digs into the skin¿ and ¿the seams on the sling are hard sharp like coorse sand paper.¿.
Additional Manufacturer Narrative
The customer reported that the seam around the opening has become very irritating to the skin and digs into the skin, and the customer developed sores; the customer also reported that the seams on the sling are hard sharp like coorse sand paper.Medline received one sling in used condition, the mesh material and the loops were all intact with some wear visible, and functional/visual inspection was performed.Upon investigation, the seam around the commode opening had rough stitching where the seam material overlaps, and the customer complaint has been confirmed.The updated cause code is defect confirmed: unknown responsible party, cannot determine cause w/received sample; the division will monitor through trending.There were no reports of death, serious injury, medical intervention, or follow up care.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.This medical device report (mdr) is being submitted as part of retrospective review activities, which include review of historical data in accordance with regulations at 21 cfr part 803.The information included in this mdr reflects the information reasonably known to the manufacturer at the time of this retrospective review and submission.

• Brand Name: MEDLINE
• Common Device Name: SLING,FULL BODY MESH WITH COMMODE,MEDIU
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kehkashan khan ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50775280
• Report Number: 1417592-2026-40824
• Device Sequence Number: 16105776
• Product Code: FSA
• UDI-Device Identifier: 10884389120637
• UDI-Public: 10884389120637
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MDSMR114
• Device Lot Number: 52523110001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown