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ESSURE Adverse Event — Injury (MDR 2951250-2020-05798)

ESSURE Adverse Event — Injury (MDR 2951250-2020-05798) 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.

DeviceESSURE
Generic nameTRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
ManufacturerBAYER PHARMA AG
Report number2951250-2020-05798
Event typeInjury
Product problemN
Date received2020-04-28
Report sourceCONSUMER, OTHER
NarrativeTHIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. THE DURATION OF USE WAS 5 YEARS. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGE
SourceopenFDA MAUDE (device adverse events)

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