MAUDE Adverse Event Report: MOLNLYCKE HEALTHCARE, US LLC BIOGEL PL; SURGEON'S GLOVES

Catalog Number 41175

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 08/10/2021

Event Type  malfunction  

Event Description

A hair was found upon opening the packaging of a sterile glove.

Event Description

A hair was found upon opening the packaging of a sterile glove.

• Brand Name: BIOGEL PL
• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE, US LLC; 5445 triangle parkway; suite 400; peachtree corners GA 30092
• MDR Report Key: 12845551
• MDR Text Key: 281036337
• Report Number: 12845551
• 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,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 41175
• Device Lot Number: 21D161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1