MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; FOAM RING COMPRESSED, RETAIL, EA

Catalog Number	MSCRINGCH
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Other
Event or Problem Description
It was reported that "seams are coming apart and busted.".
Additional Manufacturer Narrative
The customer reported the foam ring had seams coming apart and busted.Based on the photo evidence provided by the customer, one photograph was received for evaluation, showing a foam ring with a seam that appears to be coming apart.Upon review of the submitted photograph, the reported defect is confirmed; however, the photograph does not provide sufficient information to determine when or how the condition occurred.Therefore, based on the information available, the root cause of the seam separation cannot be conclusively determined and is classified as unknown.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: FOAM RING COMPRESSED, RETAIL, EA
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: venkata chittajallu ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50931792
• Report Number: 1417592-2026-52882
• Device Sequence Number: 13445424
• Product Code: KIC
• UDI-Device Identifier: 00888277728700
• UDI-Public: 00888277728700
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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

• Device Catalogue Number: MSCRINGCH
• 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: 01/17/2025
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (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