• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH Back to Search Results
Catalog Number 5950008
Device Problem Folded
Event Date 11/03/2016
Event Type  Injury  
Event Description

It was reported to davol that on (b)(6) 2016 the patient was implanted with a bard ventralex st hernia patch. Following implant it is reported that the patient developed a non healing, draining wound overlying the mesh with pain and overall fatigue. There was a concern for mesh infection. As reported on (b)(6) 2016 the patient was brought to surgery for a laparoscopic procedure. The mesh was found to have folded over with adhesions, including some to the bowel. The adhesions were released, with no injury to the bowel and the procedure was then transitioned to open and the mesh was removed. The defect was repaired with suture.

 
Manufacturer Narrative

As reported one month post implant the mesh was explanted. It is reported that the sample is being returned for evaluation; however has not been received to date. At this time no conclusions can be made. If/when the sample is returned a supplemental mdr will be submitted to document our findings. 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.

 
Manufacturer Narrative

Visual evaluation of the returned ventralex st found the sample to be folded with tissue attached on both sides. Half of the sample appears to have tissue ingrowth on the mesh layer. The pdo ring remains intact. Visual evaluation found no evidence of fixation. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Based on the sample condition and available information, there is no way to definitively determine a cause for the reported conditions. 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRALEX ST
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 Key6134649
Report Number1213643-2016-00542
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date04/30/2018
Device Catalogue Number5950008
Device LOT NumberHUAR0249
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/09/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received12/09/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/31/2016
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: 11/30/2016 Patient Sequence Number: 1
-
-