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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH Back to Search Results
Catalog Number 5950008
Device Problems Folded; Material Deformation
Event Date 03/08/2016
Event Type  Injury  
Manufacturer Narrative

Based on the information available at this time, no definitive conclusions can be made. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Adhesion is a known inherent risk of the procedure and is listed in the ifu as a possible complication. Additionally, the mesh remains implanted and is therefore not available for evaluation. Based on the limited information provided, the cause of the alleged "tacoed" mesh is unclear at this time. 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. Additionally, patient details are unobtainable due to the privacy laws in (b)(6). Device remains implanted.

 
Event Description

The following was reported to davol: it is reported that on (b)(6) 2016, the patient underwent open hernia repair surgery and was implanted with a ventralex st hernia patch. As reported prolene sutures were used to secure the mesh with four sutures placed "inside the pocket. " there was no trauma experienced by the patient in the initial post operative period. On (b)(6) 2016 the patient returned to the or with a bowel obstruction and bowel was found to be twisted and adhered to the center of the ventralex st hernia patch. The bowel was taken down easily with a grasper and at that point a secondary piece of bowel was found to have adhered to the underside of the mesh as the mesh had "tacoed. " the mesh was left implanted in the patient.

 
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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 Key5532380
Report Number1213643-2016-00124
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 03/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5950008
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received03/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 03/29/2016 Patient Sequence Number: 1
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