MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE, SURG, DERMASSURE GRN, LF, PF, 6.0

Catalog Number	MSG6560
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "a pinhole was found upon opening.".
Additional Manufacturer Narrative
The customer reported "a pinhole was found upon opening," and the japan qa comment stated, "confirmed as reported.There is a 2mm pinhole in the cuff of the left glove." medline initiated an investigation using the information provided; photo received: no, sample received: no, picture / sample evaluation: n/a, and label/ifu/ testing review: no.In the absence of a physical sample, medline was unable to confirm the presence of a defect during this investigation, and the cause was "sample required to determine cause." there were no reports of death or serious injury associated with this event, and the quality team will continue to monitor for trending.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: GLOVE, SURG, DERMASSURE GRN, LF, PF, 6.0
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: michael mazeska ; three lakes drive; northfield, IL
• MDR Report Key: 50691370
• Report Number: 1417592-2026-34695
• Device Sequence Number: 15856602
• Product Code: KGO
• UDI-Device Identifier: 10888277346543
• UDI-Public: 10888277346543
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K192988
• 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): 09/04/2026

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: MSG6560
• Device Lot Number: UNKNOWN
• 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: 12/05/2025
• Initial Report FDA Received Date: 09/09/2026
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown