• 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. MESH - COMPOSIX KUGEL 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. MESH - COMPOSIX KUGEL SURGICAL MESH Back to Search Results
Catalog Number 0010206
Device Problems Break (1069); Defective Device (2588); Folded (2630); Material Deformation (2976)
Patient Problems Adhesion(s) (1695); Hernia (2240); Disability (2371)
Event Date 05/15/2015
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. Based on the information provided it was alleged the patient experienced adhesions of mesh, alleged folded mesh and ring break. Adhesions are listed as a known possible adverse reaction in the instructions-for-use. In regards to the allegation of ring break, the device was not returned for evaluation therefore the allegation of ring break can not be confirmed and the reason for the ring break can not be determined. The patient's medical history between the date of implant in (b)(6) 2004 and the date of explant in 2015 is unknown at this time. Without a lot number a review of the manufacturing records could not be conducted. With the currently available information, no conclusion can be drawn. If additional event and/or evaluation information is obtained, a follow up 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. Not returned to manufacturer.
 
Event Description
The following was reported to davol by the patient's attorney: on (b)(6) 2004 - the patient underwent implant of the bard composix kugel mesh patch to treat a ventral hernia. On (b)(6) 2015 - the patient was admitted to the hospital for emergency surgery to remove the composix kugel mesh patch and repair a recurrent incarcerated ventral hernia. The surgeon removing the mesh patch noted " a lot of adhesions stuck to the mesh" and subsequently performed extensive lysis of the adhesions. The surgeon also noted that there were points where the mesh had "curled up onto itself and folded backwards causing the bowel to be stuck to the polypropylene part of the mesh. " the surgeon identified the composix kugel mesh patch as the source of the patient's bowel injuries and determined that there was no way to unfold the mesh. Upon inspection of the mesh, the surgeon found that "the polyester ring holding the mesh flat had broken in multiple places. " the attorney alleges the patient has experienced significant mental and physical pain and suffering, sustained permanent injury, has undergone medical treatment and will likely undergo further medical treatment and procedures, recurrence, adhesions and curled/folded mesh.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key6519560
MDR Text Key73620922
Report Number1213643-2017-00272
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/28/2008
Device Catalogue Number0010206
Device Lot Number43END417
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/29/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0524-06

Patient Treatment Data
Date Received: 04/25/2017 Patient Sequence Number: 1
-
-