MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; SLING,MESH,FULL BODY,LARGE

Catalog Number	MDSMR111
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "sling is tore on both sides.".
Additional Manufacturer Narrative
The customer reported that the sling was not received this way, the "sling is tore on both sides," and the reporter stated the strap had frayed and the sling material has separated where the strap is attached to the sling body.A photo depicting the defect was provided and only a visual review of the defect could be conducted; a physical sample was not provided, and a functional or dimensional inspection could not be executed via a photo.The investigation results were confirmed.After reviewing the photo, the center sling straps appear to have ripped off the mesh material and the material is ripping near both bottom straps; given the evidence provided in the photo the root cause of this issue is unknown, and the result will be incorporated into monthly and quarterly 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,MESH,FULL BODY,LARGE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: sullivan bluhm ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50528738
• Report Number: 1417592-2026-28715
• Device Sequence Number: 6012586
• Product Code: FSA
• UDI-Device Identifier: 10884389128749
• UDI-Public: 10884389128749
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/31/2026

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: MDSMR111
• Was Device Available for Evaluation?: Yes
• 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: 01/19/2023
• Initial Report FDA Received Date: 08/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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