• 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 Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Injury (2348); Disability (2371)
Event Date 09/02/2010
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges that the patient had subsequent surgical intervention and "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient"; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard/davol mesh ¿ composix kugel (device #2). Additional emdrs were submitted to represent the bard/davol mesh ¿ composix kugel (device #3) and three bard meshes (bard flat mesh) (device #1, device #4, device #5). Should additional information be provided, a supplemental emdr will be submitted. Not returned.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of unspecified three bard meshes (bard flat mesh) on (b)(6) 2007, (b)(6) 2012 and (b)(6) 2018 and two bard/davol composix kugel hernia patches on (b)(6) 2008 and (b)(6) 2010. As reported, the patient is making a claim for an adverse patient outcome against all devices. It is alleged that the patient underwent multiple surgeries for the revision and/or removal of hernia mesh on or about (b)(6) 2008, (b)(6) 2010, (b)(6) 2011 and (b)(6) 2018. Attorney alleges general allegations for ¿past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. " it is also alleged that the patient experienced emotional distress and 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 Key11320195
MDR Text Key231563826
Report Number1213643-2021-01004
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061314
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 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received02/09/2021
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: 02/12/2021 Patient Sequence Number: 1
-
-