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

Catalog Number	MDSMR113
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the concern is the tags are completely coming off.".
Additional Manufacturer Narrative
The customer reported that the tags came off the slings, and that the tag just rips right off or was off after they washed it and they followed manufacturer¿s laundry instructions; no injury reported.A physical sample was not provided, and a photo depicting the defect was provided and only a visual review of the defect could be conducted.The investigation results were confirmed; the manufacturing tag on the sling appears to be ripping apart, another tag appears to be completely ripped off, and it does not appear that any other parts of the nylon, stitching, or seam of the sling appears to be ripped.Given the evidence provided in the photo the root cause of this issue is unknown, the tag appears to be the only defect reported in this complaint, and 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,SOLID,FULL BODY,LARGE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: ayan asim ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50927906
• Report Number: 1417592-2026-52814
• Device Sequence Number: 18516125
• Product Code: FSA
• UDI-Device Identifier: 10884389128756
• UDI-Public: 10884389128756
• 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): 09/28/2026

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: MDSMR113
• Device Lot Number: 525220600
• 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: 04/09/2024
• Initial Report FDA Received Date: 09/29/2026
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown