• 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 0010202
Device Problems Break (1069); Defective Device (2588); Folded (2630); Material Deformation (2976)
Patient Problems Abscess (1690); Fistula (1862); Unspecified Infection (1930); Disability (2371)
Event Date 01/04/2015
Event Type  Injury  
Manufacturer Narrative
Addendum to the initial report. This supplemental emdr is being sent due to new attorney information. To date no medical records have been provided. Based on the new information provided, it is alleged the patient experienced pain, infection, abscess, ring break, ring weld break and explant. In regards to infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ in regards to the allegations of ring break and ring weld break, no sample has been returned for evaluation, therefore the allegation of ring break/ring weld break can not be confirmed and the cause for the alleged break can not be determined at this time. It was originally alleged that the patient underwent additional medical procedures after the excision of the bard composix kugel hernia mesh, however, the new legal claim provided does not reference any type of additional medical treatments following the explant of the mesh device. A manufacturing review was performed and found no anomalies during the manufacturing process of the device. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. The subject product is part of the composix kugel recall.
 
Event Description
The following was reported to davol by the patient's attorney: on (b)(6) 2004 - the patient underwent ventral hernia repair with implant of a bard composix kugel hernia mesh. On (b)(6) 2014 - the patient presented to the er with complaints of abdominal pain, bloating and chills; a cat scan was performed and a large collection of fluid identified in the abdominal wall. The patient was discharged for follow up as outpatient. On (b)(6) 2014 - due to increasing pain the patient returned to the er and was transferred to another hospital due to the complexity of the abscess. The patient was evaluated by an infectious disease specialist who noted that the infection was likely due to the mesh and would require removal of the composix kugel. On (b)(6) 2015 - the patient underwent an explant surgery where the surgeon noted that the mesh had retracted and folded on itself in the lateral aspect of the wound, and the ring of the mesh was fractured at the midportion of the oval, where the ring was welded. The attorney alleges the patient experienced pain, infection, abscess, ring break, ring weld break, disability and explant.
 
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date medical records have not been provided. It is alleged the patient experienced pain, fistula, abscess, material deformation, ring break, additional surgery and explant. Fistula is listed as a known adverse event in the instructions-for-use. In regards to the allegation of a ring break, no sample was returned for evaluation, therefore the allegation of ring break can not be confirmed or determined at this time. With the currently available information, no definitive conclusion can be drawn. A manufacturing review was performed and found no evidence of a manufacturing related cause for the alleged event. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. The subject product is part of the composix kugel recall. 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 - patient underwent surgery to repair a ventral hernia, with implant of a bard composix kugel hernia patch. On (b)(6) 2014 - patient developed severe abdominal pain. On (b)(6) 2015 - patient was admitted to the hospital. Doctors first performed an irrigation and debridement of an abdominal wall abscess. On (b)(6) 2015 - the patient underwent a subsequent surgery which included irrigation and debridement of subcutaneous tissue; explant of the bard composix kugel mesh; inlay of vicryl mesh and placement of wound vac. In the operative report, the surgeon noted that the mesh had retracted and folded on itself in the lateral aspect of the wound. In an addendum to the operative report, the surgeon confirmed that the ring of the mesh was fractured at the mid portion of the oval, where the ring was possibly welded. On (b)(6) 2015 - patient underwent picc line placement and two additional invasive surgical procedures in the days following the removal of the ck hernia patch, due in part to the formation of an enterocutaneous fistula. On (b)(6) 2015 - over the course of his recovery, patient was treated with a wound vac that was placed over a large abdominal opening that required routine cleaning and changing, and treatments to the edge of the opening to prevent closure. This process was painful and difficult for the patient, in addition to requiring extensive home health care and follow up doctor visits. It is alleged the patient experienced pain, fistula, abscess material deformation, ring break, fistula, disfigurement and explant.
 
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 Key6299705
MDR Text Key252910058
Report Number1213643-2017-00069
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,Followup
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2008
Device Catalogue Number0010202
Device Lot Number43KND419
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 Manufactured11/25/2003
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0760-06

Patient Treatment Data
Date Received: 02/03/2017 Patient Sequence Number: 1
-
-