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

Catalog Number 0112680

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

Patient Problems Incontinence (1928); Unspecified Infection (1930); Prolapse (2475)

Event Date 05/16/2013

Event Type  Injury  

Manufacturer Narrative

At this time no conclusions can be made.The patient's attorney alleges surgical intervention and that the patient underwent anterior/posterior repair of cystocele, rectocele, incontinence.A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification.Regarding 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." should additional information be provided a supplemental emdr will be submitted.Not returned.

Event Description

The following was alleged by the patient's attorney: on(b)(6) 2007: the patient was diagnosed with a rectocele, cystocele, stress urinary incontinence (sui) and underwent a transobturator sling procedure with implant of a non davol pelvisoft mesh and implant of a non davol pelvilace mesh for a cystocele/rectocele repair.On (b)(6) 2010: the patient was diagnosed with urinary frequency/urgency, urethral stricture and underwent an abd sacrocolpopexy with implant of a bard/davol flat mesh plus cystoscopy with urethral dilation.On(b)(6) 2013: the patient was diagnosed with cystocele, rectocele, incontinence and underwent anterior/posterior repair with implant of a non bard/davol "advantage fit sling" and a non bard/davol "xenform" mesh.Ni/ni/ni: the patient alleges ¿bleeding, strong pain, infection, bad odor, problem with sexual relation with ex-husband, caused divorce and mental problems (feel low, self esteem), vaginal wall prolapse with first degree cystocele, overactive bladder, urinary frequency, cystocele, rectocele, incontinence¿ as a result of the implantation of the pelvic mesh product(s)." patient reports currently experiencing urinary incontinence, pain and sometimes urinary tract infection.

• 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: roxanne tidwell ; 100 crossings blvd.; warwick, RI 02886 ; 8015652300
• MDR Report Key: 8668139
• MDR Text Key: 146973029
• Report Number: 1213643-2019-04630
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016530
• UDI-Public: (01)00801741016530
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2013
• Device Catalogue Number: 0112680
• Device Lot Number: HUSD0803
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2008
• 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): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 85