MAUDE Adverse Event Report: MOLNLYCKE HEALTH CARE US LLC BIOGEL SURGEON'S GLOVES

Model Number 30485

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/22/2022

Event Type  malfunction  

Event Description

Biogel sterile surgical gloves were being opened in the or (operating room) for procedure and a bug was found on the glove that came from a closed sealed package.Bug was flattened and appeared to have been sterilized as well.

• Brand Name: BIOGEL SURGEON'S GLOVES
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTH CARE US LLC; 5445 triangle parkway; suite 400; peachtree corners GA 30092
• MDR Report Key: 15319251
• MDR Text Key: 298875916
• Report Number: 15319251
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 30485
• Device Catalogue Number: 30485
• Device Lot Number: 22A624
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1