ESSURE Adverse Event — Injury (MDR 2951250-2020-05802)
ESSURE Adverse Event — Injury (MDR 2951250-2020-05802) 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 | 2951250-2020-05802 |
| 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 EMBEDDED DEVICE ('THE LUMEN IS VISIBLE AND EMBEDDED WITH A GRAY METALLIC COILED WIRE'), DEVICE DISLOCATION ('DISPLACEMENT OF INTRAUTERINE CONTRACEPTIVE DEVICE') AND PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. B82477) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON |
| Source | openFDA MAUDE (device adverse events) |
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