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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1