• 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 BARD SOFT MESH 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 BARD SOFT MESH SURGICAL MESH Back to Search Results
Catalog Number 0117009
Device Problem Material Integrity Problem (2978)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the soft mesh was noted to have ¿jagged¿ edges after the surgeon tailored the mesh, using curved mayo scissors. The sample was reported to have been implanted in the patient, as such is not available for evaluation. There has been no patient injury reported. Based on the available information, 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. To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september, 2021. The instructions-for-use supplied with the mesh adequately describes the proper technique for implantation and states, "intact bard¿ soft mesh exhibits high burst and tensile strength. However, when custom tailoring, in special circumstances where excessive force is placed on the mesh, the following guidelines may be helpful: when cutting a notch in the mesh, a v-shape with a radiused point will withstand more force than a v-shape which comes to a sharp point. " should additional information be provided, a supplemental mdr will be submitted. Remains implanted.
 
Event Description
As reported during an open inguinal hernia repair procedure on (b)(6) 2021, the bard soft mesh was cut to size with curved mayo scissors. As reported "the cross sections were sticking out poking into the tissue. This was felt as a safety concern by the physician that this ¿jagged¿ edge could potentially damage nerves in the area or the tissue. " as reported, the size of the mesh after being cut is not known. It was reported that the mesh was used and remains implanted in the patient. As reported, there was no patient injury and the patient did not require any additional medical or surgical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBARD SOFT 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 Key12970678
MDR Text Key284179232
Report Number1213643-2021-20459
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741030864
UDI-Public(01)00801741030864
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K052155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117009
Device Lot NumberHUFV0737
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2021
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: 12/09/2021 Patient Sequence Number: 1
-
-