MAUDE Adverse Event Report: C. R. BARD, INC. PELVISOF ACELLULAR COLLAGEN BIOMESH; MESH, SURGICAL

Lot Number 06B13-2

Device Problems Material Too Rigid or Stiff (1544); Malposition of Device (2616)

Patient Problems Hemorrhage/Bleeding (1888); Device Embedded In Tissue or Plaque (3165); Dyspareunia (4505)

Event Date 05/10/2020

Event Type  Injury  

Event Description

Bard pelvisoft mesh implanted with hysterectomy and repair of pop cystocele and rectocele (2 separate pieces front wall and back wall) on (b)(6) 2007.Had to have a re-repair of rectocele and bladder suspension by a different surgeon on (b)(6) 2012.That surgeon did not encounter the bard mesh implanted in the back wall even though he opened it up to repair it.Not sure where it went.He didn't disturb the front mesh as it was holding up at that time.I got married (b)(6) 2020 and experienced severe pain and bleeding with intercourse.My husband also felt pain every time we tried.I went to my local gynecologist and tried several remedies for months to no avail.I went back to the surgeon who did the re-repair in 2012 and he said the mesh had hardened and is "sawing" its way through the flesh and is just under the skin protruding into the vagina.I am scheduled for surgery (b)(6) 2021 to snip it and try to relax it enough to get some flexibility back.He cannot remove all of it without causing further damage.Product ids: bard pelvisoft acellular collagen biomesh 1: 6x8cm ref# (b)(4) lot# 06b13-2, 2: 8x12cm ref# (b)(4) lot# 06b22-9.Fda safety report id# (b)(4).

• Brand Name: PELVISOF ACELLULAR COLLAGEN BIOMESH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 11504673
• MDR Text Key: 240360252
• Report Number: MW5100018
• Device Sequence Number: 1
• Product Code: FTM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/12/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 06B13-2
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 51 YR
• Patient Weight: 53