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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 0112680
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Incontinence (1928); Unspecified Infection (1930); Prolapse (2475)
Event Date 05/16/2013
Event Type  Injury  
Manufacturer Narrative
At this time no conclusions can be made. The patient's attorney alleges surgical intervention and that the patient underwent anterior/posterior repair of cystocele, rectocele, incontinence. A manufacturing review that included review of sterility records was performed and found that the lot was manufactured to specification. Regarding infection; the warning section of the instructions-for-use states, ¿if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. " should additional information be provided a supplemental emdr will be submitted. Not returned.
 
Event Description
The following was alleged by the patient's attorney: on(b)(6) 2007: the patient was diagnosed with a rectocele, cystocele, stress urinary incontinence (sui) and underwent a transobturator sling procedure with implant of a non davol pelvisoft mesh and implant of a non davol pelvilace mesh for a cystocele/rectocele repair. On (b)(6) 2010: the patient was diagnosed with urinary frequency/urgency, urethral stricture and underwent an abd sacrocolpopexy with implant of a bard/davol flat mesh plus cystoscopy with urethral dilation. On(b)(6) 2013: the patient was diagnosed with cystocele, rectocele, incontinence and underwent anterior/posterior repair with implant of a non bard/davol "advantage fit sling" and a non bard/davol "xenform" mesh. Ni/ni/ni: the patient alleges ¿bleeding, strong pain, infection, bad odor, problem with sexual relation with ex-husband, caused divorce and mental problems (feel low, self esteem), vaginal wall prolapse with first degree cystocele, overactive bladder, urinary frequency, cystocele, rectocele, incontinence¿ as a result of the implantation of the pelvic mesh product(s). " patient reports currently experiencing urinary incontinence, pain and sometimes urinary tract infection.
 
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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)
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 Key8668139
MDR Text Key146973029
Report Number1213643-2019-04630
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 Non-Healthcare Professional
Type of Report Initial
Report Date 06/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2013
Device Catalogue Number0112680
Device Lot NumberHUSD0803
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2008
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: 06/04/2019 Patient Sequence Number: 1
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