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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 0010302
Device Problem Hole In Material (1293)
Patient Problems Purulent Discharge (1812); Fistula (1862); Inflammation (1932)
Event Date 03/11/2017
Event Type  Injury  
Manufacturer Narrative
The explanted sample was returned for evaluation. Visual examination of the sample confirmed that there was physical damage to the polypropylene mesh side of the device. The polypropylene fibers indicate the material has been recently cut and most likely occurred during resection of the device during the explant procedure. There was an area of material deformation and holes in the center area of the eptfe layer. The center areas of the eptfe layer where the holes are noted appear to have coincided with the report of small intestine possibly adhered to or in contact with this area of the device. The holes that are present also appear to be new and most likely presented when bowel was removed from this area of the device. Based on review it is highly likely that the damage that is identified at this time happened during the revision procedure when the mesh was explanted. A review of the manufacturing records was performed and found that the lot was manufactured to specification with no materials or manufacturing anomalies identified. To date, this is the only reported complaint for this lot of (b)(4) units released for distribution on 04/24/2008. Fistula formation and inflammation are known possible complications and are identified in the adverse reaction section of the instructions-for-use. At this time no definitive conclusions can be made as to the cause of the patient¿s post-op complications. The degree to which the device may have caused or contributed is undeterminable. 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.
 
Event Description
It was reported that in 2008 the patient was treated for an incarcerated umbilical hernia and was implanted with a bard ventralex hernia patch. In (b)(6) 2017 the patient was hospitalized and diagnosed with an abdominal wall phlegmon. On (b)(6) 2017 the patient underwent an open ipom procedure. During this procedure the ventralex hernia patch was explanted. Surgeon reported that a hole was noted in the eptfe layer of patch upon explant. An intestinal fistula bearing small intestine sling were resected (15cm of small intestine in total). Anastomosis was performed and the abdominal wall was closed with simple interrupted sutures. As reported the patient is doing well, eating and drinking. Device was returned for evaluation.
 
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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 Key6475081
MDR Text Key72191299
Report Number1213643-2017-00222
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K021736
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 04/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2013
Device Catalogue Number0010302
Device Lot NumberHUSC1821
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/24/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2008
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: 04/10/2017 Patient Sequence Number: 1
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