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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED W/ KEYHOLE SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. BARD MESH PRE-SHAPED W/ KEYHOLE SURGICAL MESH Back to Search Results
Catalog Number 0113710
Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)
Patient Problems Adhesion(s) (1695); Prolapse (2475)
Event Date 02/22/2016
Event Type  Injury  
Manufacturer Narrative

At this time no conclusions can be made to what extent the bard/davol bard mesh pre-shaped w/ keyhole device may have caused or contributed to the reported event. Adhesion is a known inherent risk of surgery and is listed in the instructions-for-use as a possible complication. 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. Not returned.

 
Event Description

Per information provided by the patient's attorney, medical records & product id page: (b)(6) 1999: the patient was diagnosed with recurrent vaginal vault prolapse (anterior segment), recurrent cystocele due to midline and paravaginal defects, recurrent enterocele and recurrent stress urinary incontinence who underwent an abd sacrocolpopexy with implant of a bard/davol ¿marlex¿ flat mesh, paravaginal repair and a fascial pubovaginal sling. On (b)(6) 1999: the patient was diagnosed with obstructive voiding after pubovaginal sling, recurrent cystocele (midline) and underwent takedown of pubovaginal sling, anterior colporrhaphy with donor fascia, perineorrhaphy followed by cystoscopy. On (b)(6) 2016: the patient was diagnosed with apical anterior and posterior vaginal prolapse and underwent a sacrocolpopexy with implant of a non bard/davol ¿restorelle y¿ mesh, extensive adhesiolysis with removal of the bard/davol ¿marlex¿ flat mesh and unknown mesh, repair of cystotomy and posterior colporrhaphy. On (b)(6) 2016: the patient was diagnosed with a pelvic abscess and underwent irrigation with drainage of abscess and explant of the non bard/davol mesh.

 
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Brand NameBARD MESH PRE-SHAPED W/ KEYHOLE
Type of DeviceSURGICAL 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 Key8741556
MDR Text Key149478551
Report Number1213643-2019-05540
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK052155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 06/27/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0113710
Device LOT Number938470
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2019
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: 06/27/2019 Patient Sequence Number: 1
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