MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH; SURGICAL MESH

Catalog Number UNKAA030

Device Problems Defective Device (2588); Folded (2630); Detachment of Device or Device Component (2907)

Patient Problems Incontinence (1928); Internal Organ Perforation (1987); Prolapse (2475)

Event Date 08/18/2003

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.It was alleged by the patient's attorney that the patient experienced organ perforation.There was no information in the medical records provided to support the allegation of an organ perforation.The medical records did indicate that the patient experienced folded mesh, detachment, pain, incontinence and prolapse.Without a lot number a review of the manufacturing records could not be conducted.With the currently available information, no definitive conclusion can be drawn.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned to manufacturer.

Event Description

The following is based on a review of medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2001 - the patient was diagnosed with vaginal vault prolapse, cystourethrocele and rectocele.The patient underwent an abdominal sacrocolpopexy with a "marlex" mesh placement which was cut into 2 pieces and sewn together during implant, paravaginal repair, burch urethropexy, right salpingo-oophorectomy, rectocele repair, suprapubic cystoscopy and suprapubic catheter placement.On (b)(6) 2003 - the patient was diagnosed with a vaginal vault prolapse, rectocele, perineal descent and increased genital hiatus.The patient underwent a revision procedure of the alleged "marlex" mesh and implant of a non-bard davol graft.Per the operative report details "a few fibers of previously placed sacrocolpopexy mesh (alleged davol flat) were attached.However, the rest of the attachment along the top of the vagina had torn away and there was complete collapse of the vault." the operative details further state "this was a prolene mesh (alleged davol flat) that was folded on itself and the posterior leaf extended down 7 cm from the top and the anterior leaf about 4 cm.These were now sutured in with several prolene sutures making firm attachment both anteriorly and posteriorly.The folded mesh was then cut to a 2 cm strip and this was sutured onto the existing mesh which was still attached to the sacrum quite firmly.The attachment was made to the medial aspect of the mesh with several prolene sutures." on (b)(6) 2006 - the patient underwent a laparoscopic total gastroesophageal fundoplication.There was no mention of any visualization or involvement of the bard flat mesh.On (b)(6) 2007 - the patient contacted the surgeon with complaints of a lot of vaginal and rectal pain, pressure and cramping.The patient reported having the difficulty sitting, standing or laying down.Patient stated the pain started after using post hole digger for fence posts.On (b)(6) 2014 - the patient contacted the surgeon with complaints of increased pelvic pressure and pain with sitting and standing.The patient stated that the pain was enough to disturb her sleep.On (b)(6) 2014 - the patient had an md office visit with complaints of vaginal pain for one month with difficulty urinating.The patient stated she feels like something is blocked.Per exam notes, "suture palpable eroding at apex, brown mucosa in vagina." patient was prescribed vaginal hormone cream to treat the eroded suture.Patient was also prescribed a laxative to use for her reported constipation.The attorney alleges the patient experienced pain, urinary problems, bowel problems, recurrence and organ perforation.

Manufacturer Narrative

Addendum to the previous report.This supplemental emdr is being sent to update outcomes attributed to adverse event.Per the attorney's allegation of an organ perforation, was updated to include life-threatening.With the current information available no conclusion can be made.If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6677914
• MDR Text Key: 78722289
• Report Number: 1213643-2017-00378
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/06/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 07/27/2017
• Supplement Dates FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 65