MAUDE Adverse Event Report: BOSTON SCIENTIFIC SOLYX-MESH SYNTHETIC

Lot Number 20883194

Device Problems Expulsion (2933); Unintended Movement (3026)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 12/18/2017

Event Type  Injury  

Event Description

Upon exam with speculum md identified expulsion of mesh dropping into vagina.Patient expulsion of mesh into vaginal vault s/p surgery (b)(6) 2017.Therapy dates: (b)(6) 2017.Diagnosis for use: stage 3 rectocele, stage 2 cystocele - paravaginal defect.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: SOLYX-MESH SYNTHETIC
• Type of Device: MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 7157875
• MDR Text Key: 96232119
• Report Number: 7157875
• Device Sequence Number: 1
• Product Code: PAH
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 20883194
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2017
• Distributor Facility Aware Date: 12/18/2017
• Device Age: 1 YR
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR