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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH E/X SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. COMPOSIX MESH E/X SURGICAL MESH Back to Search Results
Catalog Number 0123810
Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)
Patient Problems Erosion (1750); Unspecified Infection (1930); Bowel Perforation (2668)
Event Date 03/09/2005
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 bowel perforation, disability, hernia recurrence, infection, and subsequent surgical intervention for mesh explant. The instructions-for-use (ifu) supplied with the device lists hernia recurrence and adhesions as possible complications. A review of the manufacturing records was performed and found that the lot was manufactured to specification. In regards to the infection, the warnings section of the ifu states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. " this emdr represents the bard/davol composix mesh e/x (device #1). An additional emdr was submitted to represent the bard/davol composix mesh e/x (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) 2004, the patient underwent surgery for repair of an incarcerated umbilical and epigastric hernia and a bard/davol composix e/x mesh was implanted to repair the hernia defect. It is alleged that on or about (b)(6) 2005, the patient underwent an additional surgery due to a hernia recurrence and a bard/davol composix e/x mesh was implanted to repair the hernia defect. It is alleged that the patient underwent an additional surgery on or about (b)(6) 2017 due to necrotizing infection of the anterior abdominal wall from a small bowel eroding into the mesh and perforating into the abdominal wall. Removal of the infected mesh, bowel resection, debridement of anterior wall, lysis of adhesions and repair of small bowel perforation was performed. It is alleged that on or about (b)(6) 2017, the patient underwent an additional surgery due to necrotizing infection of the anterior abdominal wall with involvement of the small bowel. A wound vac was placed to help with treatment. Attorney also alleges that the patient underwent additional surgeries on or about (b)(6) 2017 during which debridement of abdominal wall wound and vacuum-assisted closure device change was performed. On or about (b)(6) 2017, the patient underwent removal of the wound vac, debridement and irrigation of anterior abdominal wall and reapplication of abdominal wound vac. Attorney alleges that the patient's pain, disability, hospitalizations, and additional surgeries were caused solely as a result of the negligence of the defendants. It is alleged that the patient has suffered and continues to suffer from chronic pain, has undergone and will likely require in the further other forms of care and medical treatment. It is also alleged that the device was defective.
 
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Brand NameCOMPOSIX MESH E/X
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 Key12627601
MDR Text Key276689916
Report Number1213643-2021-08164
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K002684
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2009
Device Catalogue Number0123810
Device Lot Number43EOD273
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2004
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: 10/13/2021 Patient Sequence Number: 1
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