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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH COMPOSIX KUGEL SURGICAL MESH Back to Search Results
Catalog Number 0010205
Device Problems Defective Device (2588); Material Deformation (2976)
Patient Problems Fistula (1862); Unspecified Infection (1930); Disability (2371)
Event Date 10/19/2012
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, fistula, infection and surgical intervention; however, no details have been provided. A review of the manufacturing records was performed and found that the lot was manufactured to specification. The instructions-for-use supplied with the device list fistula formation as a possible complication. In regards to the infection, the warning section of the ifu states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection may require removal of the prosthesis. " 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 a surgery for the repair of right lower quadrant ventral hernia and a bard/davol composix kugel, mesh was implanted to repair the hernia defect. On or about (b)(6) 2012, the patient underwent surgery to remove the chronically infected mesh, which was found to be grossly contaminated, curled up, with chronic granulations and infection in that area with erosion of the mesh into the transverse colon, causing colocutaneous fistula through the medium of mesh. It is alleged that the patient was injured severely and permanently. The patient suffered pain, disability, hospitalizations and additional surgeries. It is also alleged that the patient has suffered and will continue to suffer physical pain, chronic pain, mental anguish, psychological stress, depression, has undergone and will likely require medical treatments and other forms of care. Attorney also alleges that the device was defective.

 
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Brand NameMESH COMPOSIX KUGEL
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 Key10767699
MDR Text Key214106008
Report Number1213643-2020-09891
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK061314
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 11/01/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/28/2008
Device Catalogue Number0010205
Device LOT Number43JND225
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/22/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/24/2003
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: 11/01/2020 Patient Sequence Number: 1
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