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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number 0112680
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, during insertion of a bard flat mesh, the mesh tore while suturing. The subject device is not available for evaluation. An intra operative photo was provided; however, the reported event cannot be visualized due to the poor quality of the image. Based on the information available, no conclusion can be made. Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported. Should additional information be provided, a supplemental mdr will be submitted. Not returned - remains implanted.
 
Event Description
As reported, when the surgeon attempted to suture a bard flat mesh during an open procedure on (b)(6) 2021, the mesh tore. As reported, the mesh tore from the needle site to the edges of the mesh. A 2-0 prolene sh was used. As reported, no additional graspers or surgical instruments were used with the mesh. The torn portion of the mesh was repaired with a stitch and implanted. It was reported that, there was a slight delay in the case. There was no reported patient injury.
 
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Brand NameBARD FLAT MESH
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 Key12331252
MDR Text Key266890066
Report Number1213643-2021-20254
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741016530
UDI-Public(01)00801741016530
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0112680
Device Lot NumberHUFP0915
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/24/2021
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: 08/17/2021 Patient Sequence Number: 1
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