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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/10/2020

Event Type  malfunction  

Event Description

The mirena intrauterine device (iud) was being placed for menorrhagia, during a cesarean section (c/s) after the birth of the baby and the expulsion of the placental.The mirena was inserted into the uterus using the deployment device.The iud's strings were aimed toward the cervix.The c/s proceeded to closure without any complication.Six months later, the patient requested the removal of the iud because she was experiencing heavy bleeding and was not satisfied with the iud.The gynecologist proceeded to remove the iud by it's strings and the flange that is part of the deployment device came out with the iud.The flange is not supposed to be inserted into the uterus with the iud.The flange moves along the guide as a measurement gauge.This flange would most likely not be inserted into the uterus if the cervix is closed.The flange could fall off of the guide into the postpartum, gravid uterus when deployed with the device following either birth by cesarean section or vaginal delivery.

• Brand Name: MIRENA IUD
• Type of Device: DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
• Manufacturer (Section D): BAYER; 1 bayer drive; indianola PA 15051
• MDR Report Key: 11607186
• MDR Text Key: 243619347
• Report Number: 11607186
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/24/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10585 DA