MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; PAD,REPLACEMENT,APP,W/FLAPS,AIRONE

Catalog Number	MSC80710
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "pad we got didn't hold air after putting it on the bed.".
Additional Manufacturer Narrative
The reported product problem/issue was not holding air; the complaint transcript states the pad "didn't hold air after putting it on the bed." the customer sent in only the pad without the pump, and medline was unable to evaluate without the pump to inflate the pad.The complaint was unable to be confirmed/not confirmed with received sample, and no root cause was identified.There was no reported death or serious injury, product was not being used for treatment or diagnosis, and the complaint trending report showed no negative trends for this defect or product code, indicating no need for further action 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: PAD,REPLACEMENT,APP,W/FLAPS,AIRONE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: donovan frazier ; three lakes drive; northfield 60093--275
• MDR Report Key: 50778398
• Report Number: 1417592-2026-41343
• Device Sequence Number: 9826372
• Product Code: FNM
• UDI-Device Identifier: 10080196669943
• UDI-Public: 10080196669943
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/14/2026

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: MSC80710
• 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: 07/03/2025
• Initial Report FDA Received Date: 09/15/2026
• 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 Sex: Unknown