FDA Adverse Event Injury Summary report: N

OBTRYX MESH SLING SYSTEM

MDR report key: 1061304 · Received June 13, 2008

Report

Report Number: 3005099803-2008-00711
Event Type: Injury
Date Received: June 13, 2008
Report Date: May 17, 2008
Manufacturer: BOSTON SCIENTIFIC CORPORATION
Product Code: FTL
PMA / PMN Number: K040787
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WV, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

A SHIPPING HISTORY WAS PROVIDED DISCLOSING THAT THIS FACILITY ONLY PURCHASES OBTRYX SYSTEMS, ALLOWING FOR DEVICE IDENTIFICATION AND THE MOST LIKELY LOTS USED. THE COMPLAINANT WAS UNABLE TO INDICATE THE LOCATION OF THE DEVICE (STILL IMPLANTED); THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A MID-URETHRAL SLING PROCEDURE (APPROXIMATELY 1 YEAR AGO) WHILE USING THE OBTRYX MESH SLING SYSTEM THE PHYSICIAN WENT THROUGH THE BLADDER WITH THE TROCAR. WHEN THE PHYSICIAN WENT IN WITH CYSTO HE NOTICED THE MESH IN THE BLADDER. ADDITIONAL INFO ABOUT THE CASE, FOLLOW-UP TREATMENT OR THE PT IS UNKNOWN. THE PHYSICIAN IS NO LONGER ON STAFF WITH THIS FACILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OBTRYX MESH SLING SYSTEM		FTL	BOSTON SCIENTIFIC CORPORATION	M0068505000	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention