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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 Internal Organ Perforation (1987); Pain (1994); Disability (2371)
Event Date 02/09/2000
Event Type  Injury  
Manufacturer Narrative
At this time no conclusions can be made. It is unknown to what extent the bard/davol bard flat mesh (device #1) device may have caused or contributed to the events as alleged by the patient¿s attorney. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Based on the limited information provided at this time, no conclusions can be made. This emdr represents the bard/davol bard flat mesh (device #1). An additional emdr was submitted to represent the bard/davol bard flat mesh (device #2). The patient's attorney did not make any allegations regarding the implanted bard/davol allomax device. Should additional information be provided a supplemental emdr will be submitted. Not returned.
 
Event Description
As reported, per medical records: (b)(6) 1999: the patient underwent repair of a vaginal prolapse with placement of a bard/davol flat mesh (device #1) - vaginal. On (b)(6) 2000: the patient underwent an examination under anesthesia, excision of a pedunculated polypoid hemorrhoidal skin tag 3x3cm, exploration of the right lower quadrant, incisional mass, hematoma, serosa with necrotic fat complex and excision of this complex repair in layers, exploration and excision of umbilical and epigastric hernias with reinforcement with implant of a bard/davol "marlex" davol flat (device #2) and placement of a jackson-pratt fluted drain to prevent seroma formation. On (b)(6) 2010: the patient was diagnosed with a right lower quadrant incisional hernia, recurrent midline incisional hernia, infected mesh graft (device #2) due to a chronic skin wound at the umbilicus and underwent a laparoscopy, laparotomy, removal of the bard/davol flat mesh (device #2), and implant of a bard/davol allomax biologic graft.
 
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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 Key9009035
MDR Text Key157810751
Report Number1213643-2019-08670
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 09/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2004
Device Catalogue Number0112680
Device Lot Number43FJD181
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/1999
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: 09/12/2019 Patient Sequence Number: 1
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