MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUSHION,W/C, GEL FOAM CUSHION,18X16X3,EA

Catalog Number	MSCPRC31816
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cushion collassed in the center.
Additional Manufacturer Narrative
The complaint described the reported issue as "cushion collapsed." medline reviewed the photo provided, and the lot number was not provided so medline was unable to review the dhr.The defect has been confirmed; no root cause was identified, with the cause noted as sample required to determine cause.There was no reported death or serious injury associated with this event, product was not being used for treatment or diagnosis, and a review of the complaint trending report found no negative trends at this time.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: CUSHION,W/C, GEL FOAM CUSHION,18X16X3,EA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: maya mcknight ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50886389
• Report Number: 1417592-2026-50318
• Device Sequence Number: 9799693
• Product Code: IMP
• UDI-Device Identifier: 00884389961868
• UDI-Public: 00884389961868
• 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): 09/24/2026

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: MSCPRC31816
• 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: 01/16/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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