MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SOLYX BLUE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M006850700

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2022

Event Type  malfunction  

Event Description

Solyx sling trocar was left in patient after unsuccessful attempt at placing a vaginal solyx sling.

• Brand Name: SOLYX BLUE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16003675
• MDR Text Key: 305696627
• Report Number: 16003675
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/12/2022,11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M006850700
• Device Catalogue Number: M006850700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/12/2022
• Date Report to Manufacturer: 12/19/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21535 DA
• Patient Sex: Female