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

Catalog Number	0117320
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual evaluation of the sample identifies the hole/tear in the center of the mesh as reported.Based on the condition of the mesh it appears it was handled by the user in a manner that resulted in damage that contributed to the hole/tear that was identified.Folds and creases in the edge seal and mesh indicate the 3dmax was folded during handling in preparation for implantation.In the area of the damage where the hole/tear is noted it appears that the area in question was damaged from a combination of user handling stretching of the mesh and the use of a grasper.This is indicated by monofilaments that have been pulled on, resulting in the monofilaments becoming unwoven and torn at the damaged area creating the hole/tear in the mesh.There were no manufacturing anomalies noted to the sample during review.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in april, 2019.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 on (b)(6) "019" a bard 3dmax light mesh was being used for a laparoscopic hernia repair.As reported prior to implant the mesh was found to have a hole.There was no injury to the patient or intervention.As reported, the packaging was inspected and reported to be intact.

• 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: 9087928
• Report Number: 1213643-2019-08979
• Device Sequence Number: 16793729
• Product Code: FTL
• UDI-Device Identifier: 00801741031052
• UDI-Public: (01)00801741031052
• Combination Product (Y/N): N
• PMA/510(K) Number: K091659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 01/28/2024
• Device Catalogue Number: 0117320
• Device Lot Number: HUCZ1692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1