• 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 -VENTRALEX 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 -VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number 0010301
Device Problem Insufficient Information (3190)
Patient Problems Abdominal Pain (1685); Fever (1858); Pain (1994); Disability (2371); Ambulation Difficulties (2544)
Event Date 09/14/2015
Event Type  Injury  
Manufacturer Narrative
The patient was unable to provide a lot number; therefore a review of the manufacturing records could not be conducted. Based on the information available at this time, no conclusions can be made. The patient reports that she has provided all of the information regarding her experience. If any additional information is provided, 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.
 
Event Description
The patient has reported that on (b)(6) 2009 she underwent the repair of an umbilical hernia and was implanted with a bard ventralex hernia patch. The patient reports feeling "ill" immediately and began to develop pain and fevers which became chronic in nature. The patient reports that she followed up with her implanting surgeon but states he would not remove the mesh. On (b)(6) 2015 the patient reports that she underwent explant of the patch. Following explant the patient reports her symptoms resolved.
 
Manufacturer Narrative
This is an addendum to the initial mdr to document that product identifiers have been provided. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Based on this additional information as previously made conclusions remain the same.
 
Manufacturer Narrative
This is an addendum to the previously submitted mdr's to document additional information provided. Per contact the bard ventralex hernia patch remains implanted and was not explanted as was initially reported. Based on this additional information the conclusions remains inconclusive. Should additional information be obtained a supplemental mdr will be submitted.
 
Event Description
As previously reported to davol: on (b)(6) 2009 - the patient underwent the repair of an umbilical hernia and was implanted with a bard ventralex hernia patch. The patient reports feeling "ill" immediately and began to develop pain and fevers which became chronic in nature. The patient reports that she followed up with her implanting surgeon but states he would not remove the mesh. On (b)(6) 2010 - the patient developed "burning and swelling" at the implant site. A sample patch was provided to the allergist for reactivity testing. As reported the patient did not undergo the testing. On (b)(6) 2015 - the patient underwent explant of the patch. Following explant the patient reports her symptoms resolved. This is an addendum to the previously submitted mdr's: on (b)(6) 2015 - the patient underwent tummy tuck surgery. During this procedure the surgeon identified an additional hernia in the lower abdominal area, which he repaired. Per contact the bard ventralex hernia patch remains implanted and was not explanted during this procedure as was initially reported. Currently it is reported that the area of the umbilical hernia repair is "hot" and due to this the patient is taking antibiotics. It is reported that the patient is experiencing right groin pain and that the right leg goes numb at times down to the knee and at times the patient has to use a cane to walk.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMESH -VENTRALEX
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 Key6100291
MDR Text Key59801616
Report Number1213643-2016-00520
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K021736
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup,Followup
Report Date 03/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2014
Device Catalogue Number0010301
Device Lot NumberHUTH0498
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received02/24/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/08/2009
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: 11/14/2016 Patient Sequence Number: 1
-
-