MAUDE Adverse Event Report: COOPERSURGICAL, INC. COOPER SURGICAL LAB MEDIA SAGE 1-STEP; MEDIA, REPRODUCTIVE

Lot Number 231013-018657

Patient Problem Insufficient Information (4580)

Event Date 01/27/2024

Event Type  Injury  

Event Description

21 embryos died due to quality problem in cooper surgical lab media used to develop embryos.(b)(6) 2024, coopersurgical.

• Brand Name: COOPER SURGICAL LAB MEDIA SAGE 1-STEP
• Type of Device: MEDIA, REPRODUCTIVE
• Manufacturer (Section D): COOPERSURGICAL, INC.
• MDR Report Key: 18986386
• MDR Text Key: 338795619
• Report Number: MW5153197
• Device Sequence Number: 1
• Product Code: MQL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/21/2024

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 Expiration Date: 04/12/2024
• Device Lot Number: 231013-018657
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White