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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD SOFT MESH SURGICAL MESH Back to Search Results
Catalog Number 0117009
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problem Prolapse (2475)
Event Date 06/07/2011
Event Type  Injury  
Manufacturer Narrative

At this time no conclusions can be made. The patient's attorney alleges additional medical treatment for a vaginal bulge and was diagnosed with a rectocele. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be provided a supplemental emdr will be submitted. Not returned.

 
Event Description

The following was alleged by the patient's attorney, medical records & product id page: on (b)(6) 2011 the patient was diagnosed with pelvic organ prolapse and underwent a robotic assisted sacrocolpopexy with implant of a bard/davol soft mesh followed by cystoscopy. About 4 months later on (b)(6) 2011 the patient had a post op visit and reported a vaginal bulge. Patient was examined and was diagnosed with a rectocele. Patient was recommended an additional outpatient procedure for repair.

 
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Brand NameBARD SOFT MESH
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 Key8769162
MDR Text Key150316419
Report Number1213643-2019-05820
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 07/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2015
Device Catalogue Number0117009
Device LOT NumberHUUI1416
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/16/2010
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: 07/08/2019 Patient Sequence Number: 1
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