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

Catalog Number 0112680

Device Problems Defective Device (2588); Extrusion (2934)

Patient Problems Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987)

Event Date 01/20/2012

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event.Medical records were limited to the patient's implant tracking log only.The patient's legal fact sheet alleges the patient experienced extrusion, infection and fistula formation.Both extrusion and fistula formation are listed as known possible adverse reactions in the instructions-for-use.In regards to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively.The prosthesis may not have to be removed.An unresolved infection, however, may require removal of the prosthesis.¿ a manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.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 patient, product, or procedural details to bard.

Event Description

The following is based on a review of limited medical records, the patient's legal fact sheet and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2008--patient underwent an unspecified pelvic procedure with implant of a bard/davol 3" x 6" "monofilament polypropylene" flat mesh.On (b)(6) 2012--patient was diagnosed with a rectocele first to second degree with erosion and underwent a partial explant of the mesh.Additionally the patient's legal fact sheet alleges the patient experienced pain, erosion, extrusion, infection, urinary problems, bowel problems, fistulae, recurrence, bleeding, dyspareunia, neuromuscular problems, vaginal scarring and organ perforation.

Manufacturer Narrative

Addendum to the previous report.Based on a review of medical records, the patient underwent a revision procedure on (b)(6) 2012.There was no indication in the medical records provided of any type of explant of the flat mesh as was originally alleged.With the current information available no conclusion can be made.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 patient, product, or procedural details to bard.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2008 - patient underwent a posterior colporrhaphy with use of a bard/davol flat mesh.On (b)(6) 2012 - the patient underwent a revision procedure in which redundant vaginal mucosa around the erosion area was then excised.No mention of the previously placed flat mesh in the operative dictation.

• 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: 5480218
• MDR Text Key: 39669753
• Report Number: 1213643-2016-00087
• 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: 02/15/2016

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 Expiration Date: 02/28/2013
• Device Catalogue Number: 0112680
• Device Lot Number: HUSB0273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/15/2016
• Initial Date FDA Received: 03/04/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2008
• 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: 67 YR
• Patient Weight: 84