ESSURE Adverse Event — Injury (MDR 2951250-2020-05934)
ESSURE Adverse Event — Injury (MDR 2951250-2020-05934) 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 | 2951250-2020-05934 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | CONSUMER, OTHER |
| Narrative | THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF RASH ('PAINFUL RASH ON HAND') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED RASH (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (HYSTERCTOMY). ESSURE WAS REMOVED. |
| Source | openFDA MAUDE (device adverse events) |
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