• 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. -1213643 VENTRALIGHT ST W/ ECHO 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. -1213643 VENTRALIGHT ST W/ ECHO SURGICAL MESH Back to Search Results
Catalog Number 5955600
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/17/2021
Event Type  malfunction  
Manufacturer Narrative
The subject device was returned and has been evaluated. No manufacturing anomalies were found. Evaluation finds the st coating is separated from areas on the mesh as reported, resulting in a void of the hydrogel barrier. Evaluation identified that the mesh had been hydrated by the user, how long the mesh had been hydrated for is unknown. The instructions-for-use states the mesh should be hydrated for no more than 1-3 seconds prior to use and rolled immediately to protect the bioresorbable coating. The gel is noted to be balling up and pulling away from the mesh; it is known that damage to the hydrogel may occur if the mesh is hydrated longer than the recommended 1-3 seconds. Based on the sample evaluation and the investigation performed, the separation of the hydrogel inadvertently occurred during subsequent handling and preparation for use. A review of the manufacturing records was performed for the subject lot and found that the lot was manufactured to the specification. To date, this is the only reported complaint for this manufacturing lot of 120 units released for distribution in september, 2020.
 
Event Description
As reported, during an unspecified procedure on (b)(6) 2021, a bard/davol ventralight st w/echo 6¿ mesh was hydrated (duration unknown), and placed in the patient. It was noted that the mesh was ¿separating from itself¿ and the surgeon removed this piece of mesh and placed a new piece. There was no reported patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameVENTRALIGHT ST W/ ECHO
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
8005566756
MDR Report Key11615797
MDR Text Key244384666
Report Number1213643-2021-20066
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130968
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number5955600
Device Lot NumberHUEU1430
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/24/2020
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: 04/05/2021 Patient Sequence Number: 1
-
-