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

Catalog Number	MSG9060
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on (b)(6), the gloves tore upon putting them on a surgeon for a sterile surgical procedure (a laparoscopic case).There was no harm.It was detected prior to patient use.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
According to the facility on (b)(6), the gloves tore upon putting them on a surgeon for a sterile surgical procedure (a laparoscopic case).There was no harm.It was detected prior to patient use.

• Brand Name: SENSICARE
• Common Device Name: GLOVE,SURG,SENSICARE PI,LF,PF,6.0
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25523383
• Report Number: 1417592-2026-02545
• Device Sequence Number: 10558019
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 06/16/2026

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: 01-108882773478
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 06/16/2026
• 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