ESSURE Adverse Event — Injury (MDR 2951250-2020-05665)
ESSURE Adverse Event — Injury (MDR 2951250-2020-05665) 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 | 2951250-2020-05665 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | OTHER |
| Narrative | THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (FDA, REFERENCE NUMBER: (B)(4) ON (B)(6) 2015. THE MOST RECENT INFORMATION WAS RECEIVED ON (B)(6) 2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ('HYSTERECTOMY') IN A FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW |
| Source | openFDA MAUDE (device adverse events) |
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