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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955810
Device Problems Defective Device (2588); Material Deformation (2976); Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Disability (2371); Obstruction/Occlusion (2422)
Event Date 11/21/2019
Event Type  Injury  
Manufacturer Narrative

No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, surgical intervention, infection and hernia recurrence. The instructions-for-use supplied with the device lists hernia recurrence, adhesions, infection and inflammation as possible complications. In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the prosthesis. " no lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard/davol ventralight st w/echo (device #1). An additional emdr was submitted to represent the bard/davol phasix mesh (device #2). Should additional information be provided, a supplemental emdr will be submitted. Not returned.

 
Event Description

Attorney alleges that on or about (b)(6) 2014, the patient was implanted with a non-bard davol mesh to repair an umbilical hernia. On or about (b)(6) 2015, the patient underwent an additional surgery; a bard/davol ventralight st w/echo positioning system was implanted in an attempt to repair the recurrent ventral hernia defect. Upon entering the abdomen, the surgeon noted there was a recurrent hernia defect with incarcerated omentum. Adhesions were taken down. On or about (b)(6) 2019, the patient underwent surgery to remove the infected mesh and a bard/davol phasix was implanted in an attempt to repair the recurrent ventral hernias. Upon entering the abdomen, the surgeon noted the presence of a complex partial bowel obstruction. The mesh had become matted to the small bowel and omentum. Extensive adhesions were lysed and the complex partial small bowel obstruction was released. The infected mesh was removed. It is alleged that the mesh products caused serious injury and had to be removed via invasive surgery. Attorney alleges that the patient experienced and/or continues to experience pain, inflammation, nausea, vomiting, diarrhea, chills, loss of appetite, severe pain and suffering, which have impaired plaintiff¿s activities of daily living. It also alleged that the patient is at a higher risk of severe complications during an abdominal surgery, to the extent that future abdominal operations might not be feasible. Attorney also alleges past, present, and future damages, physical disability, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. It is further alleged that the patient experienced mental anguish, emotional distress and also that the device was defective.

 
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Brand NameVENTRALIGHT ST W/ ECHO
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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10456820
MDR Text Key204525499
Report Number1213643-2020-07711
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK122436
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 08/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5955810
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
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: 08/26/2020 Patient Sequence Number: 1
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