MAUDE Adverse Event Report: Medline Industries LP MEDLINE; GLOVE,SURG, SENSICARE PI MICRO,LF,PF,7.0

Catalog Number	MSG9670
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction

• Brand Name: MEDLINE
• Common Device Name: GLOVE,SURG, SENSICARE PI MICRO,LF,PF,7.0
• Manufacturer (Section D): Medline Industries LP; three lakes dr; northfield IL 60093 -275
• Manufacturer Contact: leann gifford ; three lakes dr; northfield, IL 60093--275
• MDR Report Key: 50460033
• Report Number: 1417592-2026-09268
• Device Sequence Number: 10263746
• Product Code: KGO
• UDI-Device Identifier: 10080196417308
• UDI-Public: 10080196417308
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K193217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2026

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: MSG9670
• Device Lot Number: 602015EA70-2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2026
• Initial Report FDA Received Date: 08/26/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown