• 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. COMPOSIX L/P 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. COMPOSIX L/P SURGICAL MESH Back to Search Results
Catalog Number 0134460
Device Problems Material Puncture/Hole (1504); Defective Device (2588)
Patient Problems Pain (1994); Hernia (2240); Disability (2371)
Event Date 11/11/2015
Event Type  Injury  
Manufacturer Narrative
There is no connection that can be made at this time between the reported unspecified post-operative complications and any problem with the bard/davol device used to treat the patient. The information provided alleges patient underwent surgery to repair recurrent supraumbilical hernia; however, no medical records have been provided. Recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. It is alleged that the surgeon noted a small hole within the midportion of the bard/davol composix l/p mesh; however, no sample was returned for evaluation. Based on the limited information provided at this time, no conclusions can be made. Should additional information be provided a supplemental emdr will be submitted. Note: no sample returned.
 
Event Description
The following was alleged by the patient's attorney: (b)(6) 2011: the patient underwent a laparoscopic repair procedure of a supraumbilical hernia with implant of a bard/davol composix l/p mesh, lot number huuc0727, reference number 0134460. Due to chronic and severe abdominal pain around the area of the implanted mesh, patient had to undergo a subsequent surgery. On (b)(6) 2015: the patient underwent a subsequent surgery to repair a recurrent supraumbilical hernia. Specifically, a "laparoscopic reduction and suture repair of torn mesh previously placed for hernia repair. " the surgeon discovered a defect in the mesh. Explicitly, a small hole within the midportion of the bard/davol composix l/p mesh. As noted in the surgeon's operative report, ". There is less than 1 centimeter, perhaps 0. 7-centimeter defect in the previously placed mesh which is the area corresponding to the hernia. " as alleged, the patient has suffered serious bodily injuries that have resulted in pain and suffering, disability, mental anguish and medical and nursing care and treatment, has experienced excruciating abdominal pain in the area of the mesh implant due to a "whole" that formed in the mesh due to the alleged defective bard/davol composix l/p mesh.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCOMPOSIX L/P
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 Key8148720
MDR Text Key129879620
Report Number1213643-2018-04556
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2015
Device Catalogue Number0134460
Device Lot NumberHUUC0727
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2010
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: 12/10/2018 Patient Sequence Number: 1
-
-