MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; SLING,MESH,FULL BODY,COMMODE,XL

Catalog Number	MDSMR116
Medical Device Problem Codes	Material Separation (1562); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fall (1848); Laceration(s) (1946)
Date of Event	05/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, "the patient was being transferred via hoyer with the appropriate sling for the patient's weight from shower chair to the bed.The sling was wet from shower" and "the sling snapped mid air".The customer contact stated the patient's "head hit the hoyer leg" which resulted in "a cut on the left eyebrow".It was reported that the patient was sent to the hospital where "stiches were put in place" and patient is doing "good".It has been determined that though the event did not involve a death or serious injury, recurrence could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.
Event or Problem Description
It was reported that, "the patient was being transferred via hoyer with the appropriate sling for the patient's weight from shower chair to the bed.The sling was wet from shower" and "the sling snapped mid air".

• Brand Name: MEDLINE
• Common Device Name: SLING,MESH,FULL BODY,COMMODE,XL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 25375899
• Report Number: 1417592-2026-02035
• Device Sequence Number: 16115969
• Product Code: FSA
• UDI-Device Identifier: 10884389128770
• UDI-Public: 10884389128770
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: MDSMR116
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown