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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 0112720
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, the bard flat mesh was noted to be rigid. Additional information has been requested. The subject device was not returned for evaluation. Based on the information available and without having the sample to evaluate, 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 from this manufacturing lot of (b)(4) units released for distribution in december, 2020. Should additional information be provided, a supplemental mdr will be submitted.
 
Event Description
As reported, during an right inguinal hernia procedure on (b)(6) 2021, the bard flat mesh was noted to be rigid and difficult to manipulate. As a result, there was delay in completing the procedure. It is unknown if the mesh was implanted in the patient. There was no reported 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 Key12489413
MDR Text Key272216540
Report Number1213643-2021-20332
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0112720
Device Lot NumberHUEY0477
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 Received09/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2020
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: 09/17/2021 Patient Sequence Number: 1
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