MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP SENSICARE; GLOVE,SURG,SENSICARE PI,LF,PF,6.0

Catalog Number	MSG9060
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device was "torn upon putting on" and occurred while "putting gloves on surgeon prior to the start of a sterile surgical procedure.No effect - did not reach patient/person - detected before use or does not touch patient during use".It was also reported that this occurred during a "laparoscopic case" and has happened "multiple times".There were no reports of death, serious injury, medical intervention, or follow-up care.It has been determined that the event did not involve a death or serious injury; however, it meets the definition of a reportable malfunction, as recurrence of the malfunction could cause or contribute to death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.
Event or Problem Description
It was reported that the device was "torn upon putting on" and occurred while "putting gloves on surgeon prior to the start of a sterile surgical procedure.No effect - did not reach patient/person - detected before use or does not touch patient during use".It was also reported that this occurred during a "laparoscopic case" and has happened "multiple times".

• Brand Name: SENSICARE
• Common Device Name: GLOVE,SURG,SENSICARE PI,LF,PF,6.0
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 25551642
• Report Number: 1417592-2026-02694
• Device Sequence Number: 5560410
• Product Code: KGO
• UDI-Device Identifier: 10888277347878
• UDI-Public: 10888277347878
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2026

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: MSG9060
• Device Lot Number: 5042161760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 06/30/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown