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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); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Pain (1994); Prolapse (2475); No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown whether the device may have caused or contributed to the reported event. The patient's attorney did not allege a specific device failure or patient injury and medical records were limited to the patient's implant tracking log and implant op report only. 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. Not returned to manufacturer.
 
Event Description
The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2006--patient was diagnosed with genital prolapse. The patient underwent a posterior intravaginal slingplasty, anterior/posterior repair with implant of a bard/davol flat mesh and a tension-free tape using a non bard/davol mesh. The attorney alleges the patient experienced and unspecified adverse outcome associated to the use of the device.
 
Manufacturer Narrative
This supplemental emdr is being sent to provide the original date of awareness in which was not previously provided as well as the correct expiration date for the bard flat mesh.
 
Manufacturer Narrative
Addendum to the previous information. The supplemental emdr is being sent due to patient allegations reported to davol by the patient's attorney. The legal claim provided alleges the patient experienced pain, infection, urinary problems, bowel problems, recurrence and bleeding. In regards to infection, the warning section in 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. ¿ limited medical records which included the patients implant op report, implant tracking log, 1 page of the patient's history and physical and 2 pages of anesthesia records were provided. With the current information available no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up emdr will be submitted.
 
Event Description
The following is based on a review of limited medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2006--patient was diagnosed with genital prolapse. The patient underwent a posterior intravaginal slingplasty with a non-bard davol ivs, anterior/posterior repair with implant of a bard/davol flat mesh and a tension-free tape using a non bard/davol mesh. The attorney's legal claim alleges the patient experienced pain, infection, urinary problems, bowel problems, recurrence and bleeding.
 
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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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key6171751
MDR Text Key62314161
Report Number1213643-2016-00571
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,Followup
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/28/2010
Device Catalogue Number0112650
Device Lot Number43KPD137
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/19/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2005
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: 12/13/2016 Patient Sequence Number: 1
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