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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); Internal Organ Perforation (1987); Prolapse (2475)
Event Date 03/20/2007
Event Type  Injury  
Manufacturer Narrative
Addendum to the previous report. This supplemental emdr is being sent due to the allegation of organ perforation which is considered a life-threatening outcome attributed to adverse event. Mesh extrusion was also alleged in the attorney's legal claim, mesh extrusion is listed as a known adverse reaction in the instructions-for-use. To date no medical records have been provided which indicate any type of organ perforation experienced by the patient. A manufacturing review was performed which found no anomalies during the manufacturing of the device. 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. Updated fields.
 
Event Description
The following is based on a review of medical records and the attorney's legal claim provided to davol by the patient's attorney: on (b)(6) 2002 - the patient underwent a total abdominal hysterectomy, bilateral salpingo-oophorectomy and adhesiolysis. No additional details provided. On (b)(6) 2003 - the patient was diagnosed with a cystocele and underwent implant of a pubovaginal sling using a bard flat mesh, cystocele repair and open suprapubic tube placement followed by cystoscopy. On (b)(6) 2007 - the patient was diagnosed with foreign body in her vagina. The patient was noted to have a "less than 1cm vaginal mesh (davol flat) erosion at the apex of the anterior vaginal wall. " the patient underwent excision of a greater than a 1x1 cm piece of flat mesh. The attorney's legal claim alleges the patient experienced pain, extrusion, prolapse, dyspareunia and organ perforation.
 
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. A manufacturing review was performed and found no anomalies during the manufacturing process. With the current information available no definitive 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. Not returned to manufacturer.
 
Event Description
The following is based on a review of medical records provided to davol by the patient's attorney: on (b)(6) 2002 - the patient underwent a total abdominal hysterectomy, bilateral salpingo-oophorectomy and adhesiolysis. No additional details provided. On (b)(6) 2003 - the patient was diagnosed with a cystocele and underwent implant of a pubovaginal sling using a bard flat mesh, cystocele repair and open suprapubic tube placement followed by cystoscopy. On (b)(6) 2007 - the patient was diagnosed with foreign body in her vagina. The patient was noted to have a "less than 1cm vaginal mesh (davol flat) erosion at the apex of the anterior vaginal wall. " the patient underwent excision of a greater than a 1x1 cm piece of flat mesh.
 
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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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key6390731
MDR Text Key194977205
Report Number1213643-2017-00166
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 04/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/30/2008
Device Catalogue Number0112680
Device Lot Number43HND045
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2003
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: 03/09/2017 Patient Sequence Number: 1
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