MAUDE Adverse Event Report: Medline Industries, LP MEDLINE; GLOVE,SURG,SENSICARE,ALOE,LF,PF,8

Catalog Number	MSG1080
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "gloves are ripping when surgeon puts on.Has happened approx 10 x this past week".
Additional Manufacturer Narrative
The customer reported that gloves are ripping when surgeon puts on and has happened approximately 10 times this past week; the complaint states the issue did not occur during use and no injury occurred.One box was returned for review, and when donning 13 each of the gloves, tearing could not be replicated as the gloves were stretched to elbow length during donning; trending was performed, the lot inspection was completed with passing results, and the vendor's review of batch records and retention samples found no abnormalities or deviations.Complaint was unable to be confirmed, and no root cause was identified.No adverse trending was identified at this time, and the review indicated no need for further action.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,SENSICARE,ALOE,LF,PF,8
• Manufacturer (Section D): Medline Industries, LP; three lakes drive; northfield IL 60093 -275
• Manufacturer Contact: joseph weiske ; three lakes drive; northfield, IL 60093--275
• MDR Report Key: 50755390
• Report Number: 1417592-2026-39402
• Device Sequence Number: 21220127
• Product Code: KGO
• UDI-Device Identifier: 10080196307548
• UDI-Public: 10080196307548
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191915
• 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): 09/10/2026

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: MSG1080
• Device Lot Number: 5031908280-1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/15/2025
• 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: 08/12/2025
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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