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

Catalog Number	0117310
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The most probable root cause is the mesh was damaged during use.The sample was provided for evaluation.As received there is a visible crack in the edge seal of the mesh.The mesh fibers remain intact with no visible separation.Visual evaluation of the sample finds that the mesh has been folded/rolled prior to the attempted implantation.Based on the event as reported and sample condition, it is most probable that the cracking of the edge seal inadvertently occurred during user/device interface while the user was inserting the mesh.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in december, 2018.A review of the manufacturing records was performed and found that the lot was manufactured to specification.
Event or Problem Description
It was reported that the bard 3dmax light mesh was damaged after the doctor inserted the mesh.An image revealed that a crack was found on the mesh edge.No patient injury.Device was returned for evaluation.

• Brand Name: 3DMAX LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 9081716
• Report Number: 1213643-2019-08892
• Device Sequence Number: 16808404
• Product Code: FTL
• UDI-Device Identifier: 00801741031021
• UDI-Public: (01)00801741031021
• 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: distributor,foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: 11/28/2023
• Device Catalogue Number: 0117310
• Device Lot Number: HUCY1044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1