FDA Adverse Event Injury Summary report: N

ADVANTAGE FIT SYSTEM

MDR report key: 2784388 · Received October 11, 2012

Report

Report Number: 3005099803-2012-04693
Event Type: Injury
Date Received: October 11, 2012
Report Date: September 18, 2012
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: FTL
PMA / PMN Number: K020110
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE REPORTED LOT NUMBER, M100000197, COULD NOT BE VERIFIED; CONSEQUENTLY, THE MANUFACTURE AND EXPIRATION DATES CANNOT BE DETERMINED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING SYSTEM DURING A PROCEDURE ON (B)(6), 2011. ACCORDING TO THE PATIENT, SHE DEVELOPED URINARY TRACT AND YEAST INFECTIONS POST-PROCEDURE, AND WAS ADMINISTERED MANY DIFFERENT TYPES OF ANTIBIOTICS. SHE ALSO EXPERIENCED DYSPAREUNIA, VAGINAL DISCHARGE, ODOR, FEVER, AND CHILLS, AND RETURNED TO THE HOSPITAL FREQUENTLY FOR FOLLOW-UP VISITS. REPORTEDLY, THE PATIENT VISITED A SECOND PHYSICIAN, WHO OPINED THAT THE ADVANTAGE SLING MAY HAVE ERODED INTO HER VAGINAL WALL, AND POSSIBLY INTO HER BLADDER. THE PATIENT WAS SCHEDULED FOR A CT SCAN ON (B)(6), 2012 (RESULTS UNKNOWN). ALL OTHER INFORMATION IS UNKNOWN AND REPORTEDLY UNAVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ADVANTAGE FIT SYSTEM	MESH, SURGICAL, POLYMERIC	FTL	BOSTON SCIENTIFIC - MARLBOROUGH	M0068502110

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention