MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE BIOGEL PL ULTRATOUCH SURGICAL GLOVES; SURGEON'S GLOVES

Lot Number 22E264

Device Problem Component Missing (2306)

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

Event Date 11/16/2022

Event Type  malfunction  

Event Description

Several packages of sterile surgical gloves that were opened on the sterile filed contained only left handed gloves and could not be used.Size 7 biogel pl ultratouch.

• Brand Name: BIOGEL PL ULTRATOUCH SURGICAL GLOVES
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE; 5445 triangle parkway suite 400; peachtree corners GA 30092
• MDR Report Key: 16452252
• MDR Text Key: 310345194
• Report Number: 16452252
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 22E264
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1