ESSURE Adverse Event — Injury (MDR 2951250-2020-05673)
ESSURE Adverse Event — Injury (MDR 2951250-2020-05673) 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 | 2951250-2020-05673 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | CONSUMER, OTHER |
| Narrative | THIS CASE WAS INITIALLY RECEIVED VIA REGULATORY AUTHORITY (REFERENCE NUMBER: MW5044397) ON 12-OCT-2015. THE MOST RECENT INFORMATION WAS RECEIVED ON 22-JUN-2020. THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF GENITAL HAEMORRHAGE ('HEAVY BLEEDING') AND URINARY TRACT INFECTION ('I KEEP UTI/INFECTION (BLADDER/URINARY TRACT/VAGINAL) TYPE') IN A 37-YEAR-OLD FEMALE PATIENT |
| Source | openFDA MAUDE (device adverse events) |
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