MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; CUSHION,PRE-INFLATED,BUBBLE,18X18,EA

Catalog Number	MSCBUB1818H
Medical Device Problem Codes	Gas/Air Leak (2946); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "air bubbling from one of the seams in the cushion holes.".
Additional Manufacturer Narrative
The customer provided a movie of the replacement cushion with "air bubbling from one of the seams in the cushion holes" and stated "this is the third one to fail." medline reviewed the video provided; no lot number was available, so medline was unable to send a request to the vendor to review the production records.The complaint was confirmed from the video provided.The investigation noted this was an issue in the 2nd quarter of 2024 and that the vendor determined the maintenance frequency for the molds was too low and long term withstand voltage tests pressure was too low; it was unclear without the lot number if this cushion was manufactured before the vendor made changes, so medline will continue to monitor with quarterly trend reports.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,PRE-INFLATED,BUBBLE,18X18,EA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: daniel soto ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50913606
• Report Number: 1417592-2026-51818
• Device Sequence Number: 17485273
• Product Code: KIC
• UDI-Device Identifier: 00888277720049
• UDI-Public: 00888277720049
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/28/2026

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: MSCBUB1818H
• 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: 12/01/2024
• Initial Report FDA Received Date: 09/28/2026
• 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