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

Catalog Number UNKAA030

Device Problem Difficult to Advance (2920)

Patient Problems Abdominal Pain (1685); Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Sepsis (2067); Urinary Tract Infection (2120); Weakness (2145); Confusion/ Disorientation (2553); Foreign Body In Patient (2687)

Event Date 11/30/2012

Event Type  Death  

Event Description

On (b)(6) 1992 or 1993 - pt was implanted with "marlex" mesh.On (b)(6) 2000 - pt admitted to the hospital with increased confusion, uti and increasing weakness.The pt was diagnosed with left sided hydronephrosis and pyelonephritis secondary to klebsiella pneumonia.Pt underwent a multipart procedure with primary hernia repair.Per op notes the pt has a history of minimally functioning left kidney secondary to adhesions "possibly" from mesh.On (b)(6) 2012 - pt presented to emergency room with rectal bleeding and abd pain.The next day the pt had a colonoscopy.The colonoscope could only be advanced about 20cm due to a blockage appearing to have been from adhesion.The colonoscopy showed multiple diverticula nad a diverticular perf.Colonoscopy was terminated and pt was taken to the operating room for a multipart procedure with explant of mesh.Per op dictation, "there was also a hard foreign body attached to the return and to the mesentery of the small bowel in this area." " it was determined that the foreign body was actually a roll of marlex mesh that was attached to the rectum in the area of perf to the presacral area and the mesentery of the small bowel." on (b)(6) 2012 - pt death.Per death cert the immediate cause of death is listed as : sepsis with additional conditions leading to the cause: rectal perf caused by foreign body in rectum, complication with transvaginal mesh, and prolapsed bladder.The death certificate also lists hypotension as significant condition contributing to the cause of death but not resulting in the underlying cause.

Manufacturer Narrative

No conclusion can be made at this time as to the degree to which the alleged davol "marlex" mesh may have caused or contributed to the reported adverse outcome.Based on a review of the pt's medical records and the pt's legal fact sheet, it was found the pt was treated for adhesions and infection/sepsis.Adhesion is listed as a known adverse outcome in the instructions-for-use.The pt had a complex medical history with several surgical procedures reported and at least three "vaginal re-suspension" procedures.Without product identifiers which were not provided a review of the manufacturing records could not be conducted.If additional event and/or evaluation information is obtained, a follow up mdr 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 pt, product, or procedural details to bard.

• Brand Name: BARD FLAT MESH
• Manufacturer (Section D): DAVOL INC, SUB. C.R. BARD, INC; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITES; san geronimo industrial park; lot#1, road#3, km 79.7; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4827871
• MDR Text Key: 5839722
• Report Number: 1213643-2015-00194
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDME
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2015
• 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
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: WOUND VAC
• Patient Outcome(s): Death; Required Intervention; Disability
• Patient Age: 88 YR
• Patient Weight: 57