• 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 UNKAA016
Device Problems Break (1069); Migration or Expulsion of Device (1395); Material Twisted/Bent (2981)
Patient Problems Sepsis (2067); Disability (2371); Bowel Perforation (2668)
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 intestinal perforation, sepsis, fistula and disability; however, no details have been provided. The adverse reaction section of the instructions-for-use (ifu) supplied with the device states "if the recoil ring is cut or damaged during insertion or fixation, additional complications may include bowel or skin perforation and infection" and lists fistula as a possible complication. In regard 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, however, may require removal of the prosthesis. " no lot number has been provided; therefore, a review of the manufacturing records is not possible. Should additional information be provided, a supplemental emdr will be submitted. Note, the date of implant is estimated as (b)(6) 2006 based on the information received, as a specific implant date is not provided. Not returned.

 
Event Description

It is alleged that the patient underwent hernia repair surgery on or about 2006. During that surgery, an unspecified bard/davol composix kugel hernia patch, which included dual mesh technology and a memory recoil ring, was surgically implanted into patient's body. Subsequently, the memory recoil ring broke while inside patient's body and/or became twisted or migrated within the abdominal cavity, causing patient to suffer from intestinal perforations, ring migration through the abdominal wall, abscess formation, bowel obstruction, migration of the hernia patch, sepsis, and chronic intestinal fistulae. It is alleged that the patient has suffered and continues to suffer from serious injuries, including, but not limited to, pain and suffering, physical injuries, disability, significant disfigurement, embarrassment, mental anguish, expenses of hospitalization, medical and nursing care treatment. It is also alleged that the patient is likely require significant additional medical treatment, further surgeries and hospitalizations. It is also alleged that the device was defective.

 
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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key10271194
MDR Text Key198726651
Report Number1213643-2020-06632
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
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 07/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA016
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2020
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: 07/14/2020 Patient Sequence Number: 1
-
-