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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX SURGICAL MESH Back to Search Results
Catalog Number 0115310
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, during insertion, the edge of the 3dmax mesh was torn. The subject device was returned for evaluation. Evaluation of the sample finds multiple tears in the edge seal from handling. A larger tear had resulted in a portion of the edge seal tearing away from the mesh. This was not reported as an out of box condition. The mesh fibers at this location have been stretched and/or pulled, which is an indication this portion of the device saw increased forces when gripping the mesh during placement. Based on the sample evaluation and investigation performed, the root cause is determined to be user/device interface while handling the mesh and gripping during attempted placement. Review of manufacturing records indicate product was manufactured to specification. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in november, 2020. Sample evaluated.
 
Event Description
It was reported that, during a laparoscopic procedure on (b)(6) 2021, a bard/davol 3dmax mesh was used. It was reported that the mesh tore when gripping in order to wrap it around to place the device. No trocar was used during the procedure. As reported, the mesh was removed and the procedure was completed using a bard/davol 3dmax mid mesh. There was a 5 minute delay in the procedure due to the issue. There was no reported patient injury.
 
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Brand Name3DMAX
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 Key11811712
MDR Text Key250386359
Report Number1213643-2021-20113
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0115310
Device Lot NumberHUEX1730
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2020
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: 05/12/2021 Patient Sequence Number: 1
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