MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. SENSICARE PI WITH ALOE SURGICAL GLOVES; SURGEON'S GLOVES

Model Number 601274- MSG1060- SIZE 6

Device Problems Product Quality Problem (1506); Inadequacy of Device Shape and/or Size (1583); Structural Problem (2506); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/17/2023

Event Type  malfunction  

Event Description

Or (operating room) switched to medline gloves and since switching providers have noted multiple issues with the way the gloves fit.The fingers are too long, when sizing down they are extremely tight, and the gloves tear very easily causing surgeons to have to switch gloves several times during operations.Surgeons have noted a change in dexterity and that they cannot feel anatomic surfaces as well with these gloves either.

• Brand Name: SENSICARE PI WITH ALOE SURGICAL GLOVES
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 17001325
• MDR Text Key: 315917871
• Report Number: 17001325
• Device Sequence Number: 1
• Product Code: KGO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 601274- MSG1060- SIZE 6
• Device Catalogue Number: MSG1060
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1