MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRANSVAGINAL MESH; GYNECOLOGICAL LAPAROSCOPIC KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Prolapse (2475)

Event Date 01/01/2012

Event Type  malfunction  

Event Description

Reporter states that in 2012 she had a transvaginal mesh implanted.Since then she has been experiencing multiple infections in various areas including her esophagus, along with pain and suffering.She has undergone a total of 4 surgeries.First surgery was the placement of the mesh in 2012.Second was the explant of the mesh in (b)(6) 2015.Third was another surgery to correct bladder issues.The 4th was to treat a rectal prolapse which she believes was related to the transvaginal mesh.

• Brand Name: TRANSVAGINAL MESH
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 7376799
• MDR Text Key: 103790907
• Report Number: MW5076170
• Device Sequence Number: 1
• Product Code: OHD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR