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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.
 
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 patient injury.Addendum: as reported, the surgeon stated the bard flat mesh was rigid when compared to an unknown "light mesh" used by the surgeon.It was reported that the procedure was completed using the bard flat mesh.
 
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.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the additional information received.Based on the information received, the originally reported ¿rigidness ¿of the flat mesh is a comparison to an unknown ¿light mesh¿ the surgeon uses, and not an allegation of an defect related to the flat mesh.The flat mesh was implanted into the patient with no reported issues.Updated fields: b4, b5, d6.A (medical device implant date), g3, g6, h2, h6, h10.Should additional information be provided, a supplemental mdr will be submitted.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned - remains implanted.
 
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Brand Name
BARD FLAT MESH
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
MDR Report Key12489413
MDR Text Key272216540
Report Number1213643-2021-20332
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741016561
UDI-Public(01)00801741016561
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
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 Health Professional
Device Catalogue Number0112720
Device Lot NumberHUEY0477
Was Device Available for Evaluation? No
Date Manufacturer Received09/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age55 YR
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