• 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. SEPRAMESH IP 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. SEPRAMESH IP SURGICAL MESH Back to Search Results
Model Number 5959812
Device Problems Defective Device (2588); Extrusion (2934)
Patient Problems Unspecified Infection (1930); Seroma (2069); Disability (2371)
Event Date 02/01/2016
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. The information provided alleges the patient experienced pain, infection, seroma, drainage, granulation and extrusion of mesh. Seroma is a known known inherent risk of hernia repair surgery and both seroma and extrusion are identified in the adverse reaction section of the instructions-for-use as possible complications. In regards to the allegation of infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. " if additional event and/or evaluation information is obtained, a follow up mdr will be submitted. Not returned to manufacturer.
 
Event Description
The following was reported to davol by the patient's attorney: on (b)(6) 2014 - the patient underwent surgery for repair of multiple recurrent incisional hernias, a sepramesh ip was implanted to repair the hernia defect. After implantation of the sepramesh ip, it is alleged the patient has suffered from persistent non-healing abdominal wound, infection, drainage, granulation and seroma, for which she has to undergo multiple wound vac treatments. On (b)(6) 2015 - the patient underwent surgery for wound exploration of recurrent wound seroma and placed a wound vac. On (b)(6) 2016 - the patient underwent another surgical procedure to excise wound seromas and place a wound vac. On (b)(6) 2016 - the patient underwent an in-office excision of her mesh implant, after her physician discovered extruding mesh during her visit for wound care treatment. The attorney alleges the patient has suffered and will continue to suffer pain and was seriously and permanently injured.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSEPRAMESH IP
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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key7220203
MDR Text Key98280167
Report Number1213643-2018-00128
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 01/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2014
Device Model Number5959812
Device Catalogue Number5959812
Device Lot NumberHUWL1182
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 Received12/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/29/2012
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: 01/25/2018 Patient Sequence Number: 1
-
-