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)

Patient Problems Wound Dehiscence (1154); Pain (1994); Discharge (2225)

Event Date 05/31/1996

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event as no specific failure mode or patient injury was alleged.The medical records provided indicate the patient experienced pain, wound dehiscence and extrusion of mesh.Extrusion is listed as a known possible adverse reaction in the instructions-for-use.With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications.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.Not returned to manufacturer.

Event Description

The following is based on a review of medical records: on (b)(6) 1996 - the patient was diagnosed with uterine prolapse, cystocele, rectocele, rectovaginal fistula and mild endometriosis of the pelvic sidewalls, right greater than left.The patient underwent a total abdominal hysterectomy, appendectomy, moschowitz vaginal sling using a bard "marlex" flat mesh, burch urethropexy and a posterior repair.On (b)(6) 1996 - md office exam, the md noted "good support but there was granulation tissue." on (b)(6) 1996 - patient had an md office exam.Md noted mesh in the patient's mid portion of the vaginal cuff.The patient was given estrogen cream.On (b)(6) 1996-- patient had md office exams.It was noted that the patient still had mesh present in the vaginal vault.The patient had a series of cotton sponges placed in her vaginal vault with an enema given methylene blue.The surgeon did not note any blueness on the cotton and therefore the md decided that she did not have a fistula that could be demonstrated.On (b)(6) 1996 - the patient was diagnosed with dehiscence of superior vaginal cuff with protrusion of vaginal mesh (davol flat) secondary to enterocele repair with granulation tissue, possible rectovaginal fistula at superior superficial perineal body and no demonstrable fistula.The patient underwent excision of vaginal mesh (davol flat) and resuturing of the vaginal cuff and minimal perineoplasty.

• 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): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer Contact: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 6551362
• MDR Text Key: 74631956
• Report Number: 1213643-2017-00290
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016509
• UDI-Public: (01)00801741016509
• 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: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0112650
• Device Lot Number: 840230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 43 YR