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

Catalog Number	MDSMR140
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer contact on 9/3/2026, "the straps broke while they were lifting a resident of the facility.".
Additional Manufacturer Narrative
According to the customer contact on 9/3/2026, "the straps broke while they were lifting a resident of the facility." the customer contact reported, "the resident was being transferred back to bed following her shower, and while the resident was in the sling on the lift, the sling straps snapped completely off and the resident fell to the floor." per the customer contact, "the strange part is that there wasn't tearing or ripping, it completely and suddenly snapped off on both sides of the strap." per the customer contact, "the cnas say they did a visual inspection prior to use and didn't notice any tears" and "the sling has been washed and used many times." the customer contact noted historically, "after use, the sling is washed and hung on a line to air dry" and "it is then folded and stored in a linen room until needed." the customer contact stated, "the sling is supposed to support a weight of up to 700 lbs."[and]" the resident using the sling was 206.6 lbs.61 inches tall." the customer contact stated, "the resident sustained a femur fracture as a result of the fall." no additional information is available at this time.A sample has been requested for evaluation.It has been determined that the reported event caused or contributed to a death or 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: SLING,MESH,FULL BODY,XXL
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: alexa huskisson ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50928003
• Report Number: 1417592-2026-10473
• Device Sequence Number: 10759120
• Product Code: FSA
• UDI-Device Identifier: 10884389128787
• UDI-Public: 10884389128787
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MDSMR140
• Device Lot Number: 52524120001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 206 LB
• Patient Race: White