MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX¿ SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET

Model Number M0068504000

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 11/16/2017

Event Type  malfunction  

Event Description

Sling implanted in patient tore, it was explanted and new sling was used.

• Brand Name: OBTRYX¿ SYSTEM - CURVED
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; malborough MA 01752
• MDR Report Key: 7156538
• MDR Text Key: 96127934
• Report Number: 7156538
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/29/2019
• Device Model Number: M0068504000
• Device Lot Number: 0000035572
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 86