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

Catalog Number 0112720

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

Patient Problems Incontinence (1928); Pain (1994); Prolapse (2475)

Event Date 10/09/2008

Event Type  Injury  

Manufacturer Narrative

Due to the patient's medical and surgical history, non-bard/davol mesh and bone screws implanted, and limited clinical information received it is currently, unknown to what extent the bard/davol flat mesh device may have caused or contributed to the events as alleged by the patient¿s attorney.No operative report was provided for the procedure of (b)(6) 2007.The operative notes of the (b)(6) 2008 procedure describe the removal of ethibond stitches without making reference to the bard/davol flat mesh, making it unclear if the mesh was explanted or remains implanted in the patient.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided a supplemental 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.

Event Description

The following was alleged by the patient's attorney and medical records: (b)(6) 2007: the patient was diagnosed with a cystocele and underwent a vaginal sling with implant of a bard/davol flat mesh, cystocele repair, cystoscopy followed by a suprapubic tube placement.The implant operative report details include, ¿a sling was fashioned from soft polypropylene mesh (davol flat).This was attached to the stitches from the bone screws.The sling had been fashioned in a t-shape, and the bottom part of the t was then secured to the cardinal ligament stitches to reinforce the cystocele repair.¿ on (b)(6) 2007: the patient underwent a laparoscopic sacrocolpopexy using unspecified bone screws.No operative report has been provided.On (b)(6) 2008: the patient was diagnosed with a cystocele, rectocele and underwent a 2 part procedure which included an umbilical hernia repair, cystocele/rectocele repair with implant of a non bard/davol ¿prolift¿ mesh, cystoscopy and suprapubic tube placement.The operative report indicated that "there were ethibond stitches which had been used to approximate the cardinal ligaments during her previous repair, and these were removed.The urethra was still well-suspended, and was left alone"; however, there is no mention of visualization of the bard/davol flat mesh.On (b)(6) 2010: the patient underwent a left upper pole partial nephrectomy/ureterectomy which was complicated by postoperative wound dehiscence with a gangrenous bowel.On (b)(6) 2010: the patient underwent a bowel resection and hernia repair complicated by a long icu admission.On (b)(6) 2013: the patient had an md office exam and was diagnosed with urinary incontinence, cystocele and dyspareunia.The patient was referred to an obgyn and recommended to perform home kegal exercises.On (b)(6) 2014: the patient underwent an office cystoscopy with normal findings.On (b)(6) 2014-(b)(6) 2015: the patient underwent physical therapy treatments which included pelvic floor rehabilitation, pelvic floor muscle exercises, bladder retraining, bowel retraining, therapeutic exercise, manual therapy, patient education due to chronic voiding difficulties, dyspareunia, incontinence and overactive bladder due to ms neurogenic bladder.

• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 7702087
• MDR Text Key: 114411780
• Report Number: 1213643-2018-02430
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561
• 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: Other Caregivers
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2010
• Device Catalogue Number: 0112720
• Device Lot Number: 43EPD507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2005
• 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: 54 YR