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	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date, this is the only reported complaint for this manufacturing lot.When the investigation has been completed, a supplemental mdr will be submitted.
Event or Problem Description
It was reported that during a procedure on (b)(6) 2020, while opening the package of a 3dmax light medium right mesh, it was found that the sealed part on the outside of the mesh was folded or damaged.There was no reported patient injury.
Event or Problem Description
As reported, on (b)(6) 2020 during an unknown procedure, while opening the package of a 3dmax light medium right mesh, it was found that the sealed part on the outside of the mesh was folded or damaged.There was no reported patient injury.
Additional Manufacturer Narrative
At this time, no conclusion can be made.While the sample evaluation is anticipated it has not get begun.To date, this is the only reported complaint for this manufacturing lot.Addendum: this is an addendum to the initial mdr.This supplemental mdr was submitted to document the results of device evaluation.The subject device was returned for evaluation.The evaluation of the sample finds no visible indication that the device was handled or handled with excessive force.Visual evaluation confirms two cracks/tears in the edge seal of the mesh.Based on the sample evaluation and investigation performed, it was determined that the edge crack/splits were most probably manufacturing generated.Review of manufacturing records indicate product was manufactured to specification.H3 other text : sample evaluated.

• 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: 10765427
• Report Number: 1213643-2020-20026
• Device Sequence Number: 14251897
• 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): 11/02/2020

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: 06/28/2024
• Device Catalogue Number: 0117320
• Device Lot Number: HUDT2038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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