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ESSURE Adverse Event — Injury (MDR 2951250-2020-05921)

ESSURE Adverse Event — Injury (MDR 2951250-2020-05921) 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 number2951250-2020-05921
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 AN ADULT FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 623316) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE AND MEDROXYPROGESTERONE ACETATE (DEPO PROVERA). ON (B)(6) 2007,
SourceopenFDA MAUDE (device adverse events)

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