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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 0010301
Device Problems Detachment of Device or Device Component (2907); Extrusion (2934)
Patient Problems Unspecified Infection (1930); Pain (1994); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing records was performed and found that the lot was manufactured to specification. Recurrence and extrusion are listed in the adverse reaction section of the ifu as possible complications. Regarding infection the warning section of the ifu 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. The patient stated that he does not wish to be contacted and did not provide contact information. Therefore, we are unable to request any additional information. Based on the limited information provided, no conclusion can be made. Should the patient contact davol with additional information, a supplemental mdr will be submitted. A separate mdr was submitted to document the other bard ventralex hernia patch reported to have been implanted in 2012. 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. Remains implanted.
 
Event Description
The patient has reported to davol that in 2012 he was implanted with two ventralex hernia patches for hernia repair. Following implant the patient reports that he developed an infection and that pieces of mesh were sticking through the wound. These pieces were removed. He reports that he has recently developed another hernia and that he is experiencing worsening pain and is unable to go to the bathroom. He reports his doctor ¿looked inside of him with a camera and said the mesh is loose and is the source of the pain. ".
 
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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 Key6131665
MDR Text Key61019362
Report Number1213643-2016-00541
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K024008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 11/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2016
Device Catalogue Number0010301
Device Lot NumberHUVI0021
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received11/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2011
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: 11/29/2016 Patient Sequence Number: 1
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