• 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. 3DMAX 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. 3DMAX SURGICAL MESH Back to Search Results
Catalog Number 0115320
Device Problem Folded (2630)
Patient Problems Abdominal Pain (1685); Disability (2371)
Event Type  Injury  
Manufacturer Narrative
The contact indicated hospitalization as an event outcome on the maude event report; however the information provided does not indicate that the patient was hospitalized as a result of the alleged mesh implant. The maude event report did not include contact information, therefore we are unable to request additional event details from the contact. Based on the limited information provided, at this time no conclusion can be made as to the degree to which the mesh implant may be causing or contributing to the patient's reported post implant experience. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be obtained, a supplemental 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. Remains implanted.
 
Event Description
The following was reported via maude event report (mw 5067181): "patient called to report adverse event involving bard hernia mesh she had implanted in 2014. Patient stated she feels a lot of severe pain in her abdomen since the implantation of the mesh. She said it feels like it's folding when she bends and she doesn't know what to do. Patient stated that the implanting doctor has refused to remove the mesh. Patient lost her insurance so cannot seek a second opinion at this time. Patient said she has so much discomfort in her stomach, and that her bowels have also been affected. She said the pain is terrible at night, and she can feel hard lines and lumps in the pubic area like the mesh is folded up. ".
 
Manufacturer Narrative
The follow-up mdr is being submitted as a result of a retrospective review of davol's mdr files.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3DMAX
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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6380207
MDR Text Key69147437
Report Number1213643-2017-00152
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2019
Device Catalogue Number0115320
Device Lot NumberHUYE1726
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 Received05/31/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/21/2014
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: 03/06/2017 Patient Sequence Number: 1
-
-