MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; FOLEY SECUREMENT DEVICE SILICONE

Catalog Number	SAFESECUREH
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "(low amount of adhesive) devices stuck on for less than a day" and "( all 6 she said were a bad only stayed on 1 day ) had to use additional tape to keep them on.".
Additional Manufacturer Narrative
The customer reported a low amount of adhesive, that all 6 were faulty and only stayed on 1 day, and had to use tape.The investigation noted that no sample was available and no samples or pictures were received.The complaint could not be confirmed, and without a sample received it is difficult to determine a true root cause.The cause was documented as sample required to determine cause, and the division performs quarterly trending on all complaints received.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: FOLEY SECUREMENT DEVICE SILICONE
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: nathan bersch ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50946338
• Report Number: 1417592-2026-54229
• Device Sequence Number: 18753507
• Product Code: EYJ
• UDI-Device Identifier: 10888277678385
• UDI-Public: 10888277678385
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/29/2026

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: SAFESECUREH
• Was Device Available for Evaluation?: No
• 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: 11/03/2023
• Initial Report FDA Received Date: 09/30/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown