MAUDE Adverse Event Report: COOK BIOTECH, INC. SURGISIS PELVIC FLOOR GRAFT MESH, SURGICAL

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: SURGISIS PELVIC FLOOR GRAFT
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): COOK BIOTECH, INC.
• MDR Report Key: 12711216
• MDR Text Key: 279275291
• Report Number: MW5104980
• Device Sequence Number: 1
• Product Code: FTM
• 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