MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE, US LLC BIOGEL PI ULTRATOUCH G; SURGEON'S GLOVES

Model Number 42165

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/25/2021

Event Type  malfunction  

Event Description

Team members and physicians complaining about gloves tearing.Physician reported blood body fluid exposure from torn glove.There have been multiple verbal complaints made about these gloves tearing, especially when donning the gloves.Gloves in various sizes have torn.

• Brand Name: BIOGEL PI ULTRATOUCH G
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE, US LLC; 5550 peachtree pkwy., ste. 500; norcross GA 30092
• MDR Report Key: 11607152
• MDR Text Key: 243619967
• Report Number: 11607152
• 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: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42165
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1