MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION XENOGRAFT PELVIC FLOOR GRAFT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP

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

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

Event Type  No Answer Provided  

Event Description

I am looking for information on cook surgisis pelvic floor graft and boston scientific xenograft for pelvic floor gynecological use. I have both of these products inserted for pelvic organ prolapse & have recurring infections and other health problems since implantation. I am in (b)(6) the gynecologist who implanted these products is no longer practicing. I have not been able to get assistance or answers from other gynecologists as to whether either of these products could be causing my health problems. I am not able to get a referral to infectious disease specialist. I would appreciate any information on these products particularly any infections or shrinkage these products may cause. Cpt2101662, cpt2101664.

• Brand Name: XENOGRAFT PELVIC FLOOR GRAFT
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR APICAL VAGINAL AND UTERINE PROLAP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION
• MDR Report Key: 12711216
• MDR Text Key: 279275291
• Report Number: MW5104980
• Device Sequence Number: 2
• Product Code: OTO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/07/2021
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage