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

Model Number UNKNOWN

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/02/2019

Event Type  malfunction  

Event Description

Patient presented for hysteroscopy for intrauterine device (iud) removal after failed removal attempt in md office.The removal was complicated due to a portion of the iud that was embedded in the uterus.During removal, the iud broke leading to a small piece being retained in the uterus.Brand and model of iud is unknown to this writer.A description of iud was provided: white plastic t-shaped intrauterine device, which is 3.3 cm x 3.2 cm wrapped in orange brown coils.

• Brand Name: UNKNOWN
• Type of Device: DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9506088
• MDR Text Key: 172604020
• Report Number: 9506088
• Device Sequence Number: 1
• Product Code: HHF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 13870 DA