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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH - VENTRALEX SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. MESH - VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number 0010303
Device Problems Folded (2630); Detachment of Device or Device Component (2907); Insufficient Information (3190)
Patient Problems Purulent Discharge (1812); Fistula (1862); Unspecified Infection (1930)
Event Date 09/14/2010
Event Type  Injury  
Manufacturer Narrative
Based on the information provided, no definitive conclusions can be made. Without medical records it is unknown what "complications" presented during the implant procedure. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Fistula formation is listed as a possible complication in the adverse reaction section of the ifu. Regarding infection the warning section 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. " it is reported that within two weeks of being implanted the patch became detached from the abdominal wall and adhered to the patient's bowel. The fixation technique used to secure the device is unknown as medical records have not been provided. Regarding fixation the warning section of the ifu states, "to ensure a strong repair, the prosthesis should be secured with tacks or sutures through the polypropylene mesh straps and/or positioning pocket. Suturing or tacking on the sealed edge of the mesh alone is not recommended. " if additional information is obtained, a supplemental 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.
 
Event Description
The following was reported to davol by the patient: on (b)(6) 2010 - the patient underwent a laparoscopic incisional hernia repair with implant of a bard ventralex hernia patch. The patient stated the attending surgeon informed his wife that there had been some "complications" during the procedure; however, did not give any details as to what had occurred. The patient also stated he was not put on any antibiotics postoperatively for prevention of infection. On (b)(6) 2010 - the patient presented to the er with left abdominal incision site drainage; there was a foul smelling purulent discharge and redness. A ct scan showed an abscess and fistula formation due to the mesh becoming detached from the abdominal wall, folding over and adhering to the small bowel. He reports that he was diagnosed with a "mesh infection" and underwent an additional surgical procedure which included removal of the bard ventralex hernia patch, a small bowel resection and the implant of a non bard/davol biologic graft. On (b)(6) 2010 - the patient underwent multiple wound care procedures which included wound debridement of excessive amounts of necrotic tissue and wound dressing changes.
 
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Brand NameMESH - VENTRALEX
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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5754797
MDR Text Key48314446
Report Number1213643-2016-00291
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K021736
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 06/07/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2014
Device Catalogue Number0010303
Device Lot NumberHUTL0027
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2009
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: 06/28/2016 Patient Sequence Number: 1
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