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

Catalog Number	MSCBUB1818H
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "there is a small hole in the product causing it to leak.".
Additional Manufacturer Narrative
The customer reported "a small hole" and stated the leak is at one of the hole seams where they are heat pressed or epoxyied together; the customer found this by immersing the item in a bucket of water.The sample was provided, and medline was able to inflate the cushion but was unable to confirm there was any small hole; the customer stated they put the cushion in water and was able to see bubbles.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: 50913452
• Report Number: 1417592-2026-51803
• Device Sequence Number: 5753060
• 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): 09/25/2026

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
• Date Returned to Manufacturer: 08/28/2024
• 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: 08/15/2024
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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