• 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 LIGHT 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 LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117311
Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 06/10/2019
Event Type  malfunction  
Manufacturer Narrative
The information provided is limited, and it is unclear what the reporter means by "broken". As reported, the mesh is available for return, however, to date the sample has not been received at davol. Multiple attempts have been made to request additional information, including the return of the sample for evaluation. At this time there has been no response. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date this is the only reported complaint for this production lot of 299 units released for distribution in july 2018. Should additional information be obtained and/or the sample returned for evaluation, a supplemental emdr will be submitted. Not returned.
 
Event Description
As reported,when the surgeon opened the 3dmax light mesh on (b)(6) 2019, he found the mesh was "broken" inside package. The mesh was not used in the case. As reported, the sample is being returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3DMAX LIGHT
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 Key8753795
MDR Text Key149812620
Report Number1213643-2019-05694
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2020
Device Catalogue Number0117311
Device Lot NumberHUCT0124
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/14/2018
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: 07/02/2019 Patient Sequence Number: 1
-
-