MAUDE Adverse Event Report: LIFEGLOBAL GROUP, LLC LIFEGLOBAL® MEDIA; MEDIA, REPRODUCTIVE

Model Number LGGG-050

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/27/2023

Event Type  malfunction  

Event Description

Culture media definitely did not support embryo development to the blastocyst stage.

• Brand Name: LIFEGLOBAL® MEDIA
• Type of Device: MEDIA, REPRODUCTIVE
• Manufacturer (Section D): LIFEGLOBAL GROUP, LLC; 393 soundview road; guildford CT 06437
• MDR Report Key: 18815759
• MDR Text Key: 336648470
• Report Number: 18815759
• Device Sequence Number: 1
• Product Code: MQL
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LGGG-050
• Device Catalogue Number: LGGG-050
• Device Lot Number: 231020-018742
• 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: 11/29/2023
• Device Age: 1 MO
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 03/01/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1