ESSURE Adverse Event — Injury (MDR 2951250-2020-05814)
ESSURE Adverse Event — Injury (MDR 2951250-2020-05814) 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 | 2951250-2020-05814 |
| 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 PERFORATION ('PERFORATION'), PELVIC PAIN ('CHRONIC PELVIC PAIN') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISEASE DIAGNOSIS') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2003, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON AN UNKNOWN |
| Source | openFDA MAUDE (device adverse events) |
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