MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDIGUARD; GLOVE,SURG, ADVANTAGE PI MICRO,LF,PF,5.5

Catalog Number	AVT0655
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the new gloves feel unsafe to use during procedures.The fingers do not fit correctly and make it difficult to sew sutures safely.This brand of gloves smell badly.The surgeon also reported that they get more holes in this brand of gloves as compared with the previous gloves.The complaints are across all lots and sizes of the gloves.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.
Event or Problem Description
It was reported that, the new gloves feel unsafe to use during procedures.The fingers do not fit correctly and make it difficult to sew sutures safely.This brand of gloves smell badly.The surgeon also reported that they get more holes in this brand of gloves as compared with the previous gloves.The complaints are across all lots and sizes of the gloves.

• Brand Name: MEDIGUARD
• Common Device Name: GLOVE,SURG, ADVANTAGE PI MICRO,LF,PF,5.5
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: meghana maddilli ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25669689
• Report Number: 1417592-2026-03713
• Device Sequence Number: 12161794
• Product Code: KGO
• UDI-Device Identifier: 10197344099757
• UDI-Public: 10197344099757
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K193217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: AVT0655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/30/2026
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown