ESSURE Adverse Event — Injury (MDR 2951250-2020-05746)
ESSURE Adverse Event — Injury (MDR 2951250-2020-05746) 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 | 2951250-2020-05746 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | CONSUMER, OTHER |
| Narrative | THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF HYSTERECTOMY ('HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. IN 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2018, THE PATIENT UNDERWENT HYSTERECTOMY (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED IN (B)( |
| Source | openFDA MAUDE (device adverse events) |
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