MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PAD,ARMBOARD,CONV,FOAM,2X8X20",12PR/CS

Catalog Number	NON081343
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when they open them, they are deformed and do not inflate.
Additional Manufacturer Narrative
The complaint stated that 1006171 has been receiving these foam arm board pads and when they open them, they are deformed and do not inflate.Visual inspection was conducted with the provided pictures, and it was found that items remaining flat after the opening.At this time, the reported concern was confirmed, as the items not expanding properly.The cause was documented as comp./part defective, broke, and the issue is a known trend with the division and with the manufacturer; the division will continue to monitor the issue for 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: PAD,ARMBOARD,CONV,FOAM,2X8X20",12PR/CS
• 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: 50843078
• Report Number: 1417592-2026-46676
• Device Sequence Number: 10051405
• Product Code: CCX
• UDI-Device Identifier: 40884389122274
• UDI-Public: 40884389122274
• 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): 09/21/2026

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: NON081343
• Device Lot Number: 230621.2.EK0612
• 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: 09/11/2023
• Initial Report FDA Received Date: 09/21/2026
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown