• 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. VENTRALEXST 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. VENTRALEXST SURGICAL MESH Back to Search Results
Catalog Number 5950007
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Pain (1994); Urinary Retention (2119); Obstruction/Occlusion (2422); Bowel Perforation (2668)
Event Type  Injury  
Manufacturer Narrative
No conclusion can be made. A lot number was not provided; without a lot number a review of the manufacturing records is not possible. We have documented the product in question as a bard flat mesh as the contact has not provided specific product information. Additional information including product identifiers have been requested. Note, the date of implant is estimated based on the information provided. Should additional information be provided, a supplemental emdr will be submitted. Remains implanted.
 
Event Description
It was alleged that in (b)(6) 2014 the patient was implanted with an unspecified mesh during an unspecified procedure. As reported about 8 months after the implant procedure, the patient experienced abdominal pain and constipation. Due to these symptoms the patient went to the hospital where he was diagnosed with a bowel obstruction. The patient is currently having significant issues with his bowels, experiences urinary retention and has been to numerous doctors over the years about his issues. The contact reports the mesh has moved in the patient's stomach which is causing all of his issues. The patient has consulted with a surgeon who wants more information about the mesh he had implanted before removing the mesh from the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRALEXST
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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key9702053
MDR Text Key181576132
Report Number1213643-2020-01103
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5950007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2020
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: 02/12/2020 Patient Sequence Number: 1
-
-