MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING; MESH, SURGICAL, UROGYNECOLOGIC

Lot Number 23182541

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Itching Sensation (1943)

Event Date 05/21/2019

Event Type  malfunction  

Event Description

Patient underwent a urethropexy using vaginal tape repair and cystocele with biologic graft cystoscopy.Patient discharged to home the same surgery day.Within 30 days, the patient began to experience increasing lower abdominal pain and treated with antibiotics for a uti.The patient then began to experience itching hands/vaginal itching, and questioned if possibly allergic to the vaginal sling.The medications were stopped and patient placed on benadryl to see if itching improved.Itching continued and patient placed on prednisone; itching persisted and patient placed on atarax.The patient questioned again if she was experiencing an allergic reaction to the sling.A medrol dosepak was restarted along with vistaril- with no relief.The patient was then seen by an allergist and discussed possibility of removing sling.Approximately fifty-one days after placement of the sling, the sling was surgically removed.Since the removal of the sling the patient has experienced no further itching.

• Brand Name: ADVANTAGE FIT TRANSVAGINAL MID-URETHRAL SLING
• Type of Device: MESH, SURGICAL, UROGYNECOLOGIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 8727137
• MDR Text Key: 148989522
• Report Number: 8727137
• Device Sequence Number: 1
• Product Code: PAJ
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 23182541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16790 DA