MAUDE Adverse Event Report: LIFEGLOBAL GROUP, LLC LIFEGLOBAL MEDIA; IVF MEDIA

Model Number SEE H11

Device Problem Chemical Problem (2893)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2024

Event Type  Injury  

Manufacturer Narrative

D4: model #: lggg-020 or lggg-050 or lggg-100.Lot #: 231020-0187421 or 231020-018742 or 231020-018743.Udi#: (b)(4).G2: foreign: canada.H7: recall # 1216677-11-30-2023-001-r event id # (b)(4).Device location is unknown.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the patient was identified through the fertility patient program (fpp) as using lggg ivf product.The patient was 21 weeks 5 days pregnant on (b)(6) 2024, with a fetus identified on ultrasound as having transposition of the great arteries.The couple reportedly does not have personal or family history of cardiac defects.No additional information is available.1222779-2024-0000002 lggg 2024-04-0000020.

• Brand Name: LIFEGLOBAL MEDIA
• Type of Device: IVF MEDIA
• Manufacturer (Section D): LIFEGLOBAL GROUP, LLC; 393 soundview rd; guilford CT 06437
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: michael marone ; 50 corporate drive; trumbull, CT 06611 ; 4752651582
• MDR Report Key: 19209743
• MDR Text Key: 341357303
• Report Number: 1222779-2024-00002
• Device Sequence Number: 1
• Product Code: MQL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K053552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/29/2023
• Device Model Number: SEE H11
• Device Catalogue Number: SEE H11
• Device Lot Number: SEE H11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Congenital Anomaly
• Patient Sex: Female