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

Catalog Number 0112650

Device Problems Defective Device (2588); Extrusion (2934); Insufficient Information (3190)

Patient Problems Pain (1994); Prolapse (2475); Intermenstrual Bleeding (2665)

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown whether the device may have caused or contributed to the reported event.The attorneys report alleges mesh extrusion.Extrusion is listed in the adverse reaction section of the ifu as a possible complication.A review of the manufacturing records was performed and found that the lot was manufactured to specification.If additional 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.Not returned to manufacturer.

Event Description

The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2007 - the patient underwent treatment for stress urinary incontinence and repair of enterocele using a non-bard davol capio, xenform and tot via obtryx.On (b)(6) 2007 - the patient was diagnosed with a post hysterectomy vaginal vault prolapse.The patient underwent a transabdominal sacral colpopexy with moschowitz procedure and implant of a bard flat mesh.On (b)(6) 2007 - patient had a post op follow up visit.Patient stated she was doing well postoperatively, however, she did have complaints of urinary incontinence.On (b)(6) 2007 - upon evaluation patient was found to have urethral insufficiency.The patient underwent a tot urethral sling non-bard davol aris (coloplast) repair.There was no mention of the bard flat mesh in the operative details.On (b)(6) 2008 - patient had office visits where the patient was noted to be doing well from a surgical standpoint with no complaints of prolapse.The attorney's claim alleges the patient experienced pain, extrusion of mesh, recurrence, bleeding and urinary problems.

• 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: 5970035
• MDR Text Key: 55384907
• Report Number: 1213643-2016-00443
• 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
• Report Date: 08/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2012
• Device Catalogue Number: 0112650
• Device Lot Number: HURD0789
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2007
• 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): Other