MAUDE Adverse Event Report: BAYER MIRENA; DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER

Lot Number TUO2EOF

Device Problem Expulsion (2933)

Patient Problem Insufficient Information (4580)

Event Date 02/20/2020

Event Type  malfunction  

Event Description

Patient had an uncomplicated post-placental iud placement.9 months following placement patient was noted to have a green piece of plastic expel from her vagina.The piece is consistent with flange on the iud inserter.

• Brand Name: MIRENA
• Type of Device: DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
• Manufacturer (Section D): BAYER; 100 bayer boulevard; whippany NJ 07981
• MDR Report Key: 10945622
• MDR Text Key: 219529824
• Report Number: 10945622
• Device Sequence Number: 1
• Product Code: HDT
• 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: 12/03/2020

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 Lot Number: TUO2EOF
• 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: 12/03/2020
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA