FDA Adverse Event Injury Summary report: N

ESSURE

MDR report key: 3843832 · Received May 27, 2014

Report

Report Number: 2951250-2014-00171
Event Type: Injury
Date Received: May 27, 2014
Report Date: January 19, 2017
Manufacturer: BAYER PHARMA AG
Product Code: HHS
PMA / PMN Number: P020014
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHARMACIST
Health Professional: N

Narratives

Description of Event or Problem · 1

THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A PHARMACIST IN (B)(6) ON (B)(6) 2014 WHICH REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED ESSURE MIGRATED IN INTRAPERITONEAL PART AND WAS FOUND IN MESOCOLON AREA. NO INFORMATION GIVEN ON PATIENT'S HISTORY, PAST DRUGS AND CONCURRENT CONDITIONS. IT IS NOT REPORTED WHETHER THE PATIENT RECEIVED ANY CONCOMITANT MEDICATION. ON (B)(6) 2013, THE PATIENT HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT), LOT NUMBER B44009, INSERTED AT UNK FOR STERILIZATION. INSERTION WAS SUCCESSFUL. ON (B)(6) 2014, ESSURE ON THE LEFT SIDE WAS EXTRAUTERINE AND MIGRATED IN INTRAPERITONEAL PART SEEN ON REPEAT PLAIN ABDOMEN X-RAY, ULTRASOUND AND CT-SCAN PERFORMED 3 MONTHS AFTER THE INSERTION. CLINICAL CONSEQUENCES OBSERVED: INFECTIOUS AND HEMORRHAGIC RISKS. REMOVAL OF ESSURE WAS PERFORMED VIAL CELIOSCOPY ON (B)(6) 2014. ESSURE WAS FOUND IN MESOCOLON AREA. ESSURE WAS NOT KEPT. CASE MEDICALLY SIGNIFICANT ACCORDING TO THE REPORTER. THE OUTCOME OF THE EVENT ESSURE MIGRATED IN INTRAPERITONEAL PART AND WAS FOUND IN MESOCOLON AREA WAS UNKNOWN. REPORTER CAUSALITY WAS NOT REPORTED. NO FURTHER INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
311358	ESSURE	INSERT, TUBAL OCCLUSION	HHS	BAYER PHARMA AG	ESS305	B44009

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR	Female	Other