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

Catalog Number	0117320
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the 3dmax light mesh was folded and damaged prior to use.There was no reported patient injury.The subject device is being returned for evaluation.However, at this time has not been received.Based on the available information, we are unable to determine a definitive root cause for the reported event.To date this is the only reported complaint from this manufacturing lot.If/when the sample is received and evaluated, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that on (b)(6) 2020, the 3dmax light medium right mesh was opened prior to the procedure and noted that the mesh was folded and damaged.The alleged damage was seen around the center of the mesh.The edge was damaged by the user when the mesh was grasped by forceps.The procedure was completed by using another mesh.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the 3dmax light mesh was folded and damaged prior to use.There was no reported patient injury.The subject device is being returned for evaluation.However, at this time has not been received.Based on the available information, we are unable to determine a definitive root cause for the reported event.To date this is the only reported complaint from this manufacturing lot.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr was submitted to document the result the sample evaluation.Evaluation of the sample finds the mesh is contaminated with bodily fluids and is creased from handling and attempted deployment using forceps.There is a tear noted in the center of the mesh and along the edge as reported.Based on the sample evaluation, the reported condition is confirmed and caused by user/device interface during attempted placement of the mesh with forceps as reported.The instructions-for-use provided with the device states ¿use an appropriate sized trocar to allow mesh to slide down the trocar with minimal force.¿ updated fields: b4, d10, g4, g7, h2, h3, h6, h10 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.
Event or Problem Description
It was reported that on (b)(6) 2020, the 3dmax light medium right mesh was opened prior to the procedure and noted that the mesh was folded and damaged.The alleged damage was seen around the center of the mesh.The edge was damaged by the user when the mesh was grasped by forceps.The procedure was completed by using another mesh.There was no reported patient injury.

• Brand Name: 3DMAX LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 11097627
• Report Number: 1213643-2020-20090
• Device Sequence Number: 847295
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 0117320
• Device Lot Number: HUEQ0349
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 12/28/2020
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 01/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other