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

Catalog Number 0117321

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 1314 units released for distribution in september, 2020.When the sample evaluation is completed, a supplemental mdr will be submitted.

Event Description

As reported, while opening the package containing a bard/davol 3dmax light mesh during a procedure on (b)(6) 2021, it was noted that the mesh was torn.As reported, the mesh was not handled using a trocar.There was no reported patient injury.

Event Description

As reported, while opening the package containing a bard/davol 3dmax light mesh during a procedure on (b)(6) 2021, it was noted that the mesh was torn.As reported, the mesh was not handled using a trocar.There was no reported patient injury.

Manufacturer Narrative

At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.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 september, 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the results of the sample evaluation.Visual evaluation of the returned sample indicates the mesh is unused, and has not been handled with excessive force.Visual evaluation confirms one (1) tear in the edge seal of the mesh.As reported, the tear was noted as an out of box condition, when opening the package.Based on the sample evaluation and investigation performed, it was determined that the tear was most probably manufacturing generated.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 : sample evaluated.

• Brand Name: 3DMAX LIGHT
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11570855
• MDR Text Key: 242455008
• Report Number: 1213643-2021-20061
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069
• Combination Product (y/n): N
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2022
• Device Catalogue Number: 0117321
• Device Lot Number: HUES0595
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other