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

Catalog Number	MDSMR113
Medical Device Problem Codes	Material Discolored (1170); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: SLING,SOLID,FULL BODY,LARGE
• Manufacturer (Section D): SLING,SOLID,FULL BODY,LARGE; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: kumar vigrahala ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50615191
• Report Number: 1417592-2026-32575
• Device Sequence Number: 10573934
• 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): 09/02/2026

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
• 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: Not provided
• Initial Report FDA Received Date: 09/04/2026
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 190 LB