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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); Extrusion (2934)
Patient Problems Erosion (1750); Unspecified Infection (1930); Internal Organ Perforation (1987)
Event Date 01/20/2012
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event.Medical records were limited to the patient's implant tracking log only.The patient's legal fact sheet alleges the patient experienced extrusion, infection and fistula formation.Both extrusion and fistula formation are listed as known possible adverse reactions in the instructions-for-use.In regards to 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.An unresolved infection, however, may require removal of the prosthesis.¿ a manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event.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.
 
Event Description
The following is based on a review of limited medical records, the patient's legal fact sheet and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2008--patient underwent an unspecified pelvic procedure with implant of a bard/davol 3" x 6" "monofilament polypropylene" flat mesh.On (b)(6) 2012--patient was diagnosed with a rectocele first to second degree with erosion and underwent a partial explant of the mesh.Additionally the patient's legal fact sheet alleges the patient experienced pain, erosion, extrusion, infection, urinary problems, bowel problems, fistulae, recurrence, bleeding, dyspareunia, neuromuscular problems, vaginal scarring and organ perforation.
 
Manufacturer Narrative
Addendum to the previous report.Based on a review of medical records, the patient underwent a revision procedure on (b)(6) 2012.There was no indication in the medical records provided of any type of explant of the flat mesh as was originally alleged.With the current information available no conclusion can be made.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.
 
Event Description
The following is based on a review of medical records provided to davol by the patient's attorney: (b)(6) 2008 - patient underwent a posterior colporrhaphy with use of a bard/davol flat mesh.On (b)(6) 2012 - the patient underwent a revision procedure in which redundant vaginal mucosa around the erosion area was then excised.No mention of the previously placed flat mesh in the operative dictation.
 
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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)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key5480218
MDR Text Key39669753
Report Number1213643-2016-00087
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,Followup
Report Date 02/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/28/2013
Device Catalogue Number0112680
Device Lot NumberHUSB0273
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Initial Date Manufacturer Received 02/15/2016
Initial Date FDA Received03/04/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received04/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2008
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
Patient Age67 YR
Patient Weight84
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