MAUDE Adverse Event Report: COOPERSURGICAL INC. COOPER SURGICAL GLOBAL MEDIA; MEDIA, REPRODUCTIVE

Lot Number 230922-017934

Event Date 11/20/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 i had an ivf(in vitro fertilisation) egg retrieval done which yielded 12 eggs, 8 of which fertilized.All embryos arrested development on day 3 and failed to make it to blastocyst stage.Cooper surgical global media used with lot #230922-017934.

• Brand Name: COOPER SURGICAL GLOBAL MEDIA
• Type of Device: MEDIA, REPRODUCTIVE
• Manufacturer (Section D): COOPERSURGICAL INC.
• MDR Report Key: 18704518
• MDR Text Key: 335461748
• Report Number: MW5151585
• Device Sequence Number: 1
• Product Code: MQL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/08/2024

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?: No
• Device Lot Number: 230922-017934
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31 YR
• Patient Sex: Female