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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH SURGICAL MESH Back to Search Results
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.
 
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Brand NameBARD FLAT MESH
Type of DeviceSURGICAL 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 Key6551362
MDR Text Key74631956
Report Number1213643-2017-00290
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
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 Received05/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112650
Device Lot Number840230
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2017
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 Treatment Data
Date Received: 05/08/2017 Patient Sequence Number: 1
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