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

Catalog Number 31475

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

After completing a lumbar puncture, found a 3mm hole in the glove.

• Type of Device: SURGEON'S GLOVES
• Manufacturer (Section D): MOLNLYCKE HEALTHCARE, US LLC; 5550 peachtree parkway; suite 500; norcross GA 30092
• MDR Report Key: 9082015
• MDR Text Key: 159018271
• Report Number: 9082015
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 31475
• Device Lot Number: (10)18K448
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2019
• Type of Device Usage: N
• Patient Sequence Number: 1