ESSURE Adverse Event — Injury (MDR 2951250-2020-05901)
ESSURE Adverse Event — Injury (MDR 2951250-2020-05901) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ESSURE; Generic name: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE; Manufacturer: BAYER PHARMA AG.
| Device | ESSURE |
|---|---|
| Generic name | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE |
| Manufacturer | BAYER PHARMA AG |
| Report number | 2951250-2020-05901 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER, OTHER |
| Narrative | THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('1 MM PIECE OF PROXIMAL PLATINUM MARKER OF THE IMPLANT FRACTURED') AND GENITAL HAEMORRHAGE ('EXCESSIVE SPOTTING') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. IN 2009, THE PATIENT EXPE |
| Source | openFDA MAUDE (device adverse events) |
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