FDA Adverse Event Injury Summary report: N

PFR KIT ? UPHOLD LITE VAGINAL SUPPORT SYSTEM

MDR report key: 3871168 · Received June 13, 2014

Report

Report Number: 3005099803-2014-02207
Event Type: Injury
Date Received: June 13, 2014
Report Date: May 21, 2014
Manufacturer: BOSTON SCIENTIFIC - MARLBOROUGH
Product Code: OTP
PMA / PMN Number: K122459
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: UT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD LITE VAGINAL SUPPORT SYSTEM WAS USED DURING AN ANTERIOR APICAL REPAIR PROCEDURE IN 2010. THE EXACT DATE IS UNKNOWN. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO COMPLICATIONS REPORTED IMMEDIATELY AT THE CONCLUSION OF THE PROCEDURE. ACCORDING TO THE COMPLAINANT, POST PROCEDURE, THE PATIENT STARTED TO EXPERIENCE BUTTOCK PAIN AND DYSPAREUNIA. THE DEVICE WAS EXPLANTED ON (B)(6) 2014. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
350974	PFR KIT ? UPHOLD LITE VAGINAL SUPPORT SYSTEM	MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR	OTP	BOSTON SCIENTIFIC - MARLBOROUGH	M0068317170

Patients

Seq	Age	Sex	Outcome	Treatment
1	58 YR		Required Intervention