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

Catalog Number	0115322
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject product was discarded by the user facility and not returned for evaluation.Based on the information provided this was not an out of box condition and may have been the result of product manipulation by the user.However, without having the sample to evaluate no conclusion can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in october, 2018 discarded by user facility.
Event or Problem Description
It was reported that on (b)(6) 2019 a bard/davol 3dmax mesh was being used for a robotic inguinal hernia repair.As reported the mesh tore during attempted placement.As reported the tear was near the edge where the surgeon was grasping the mesh to insert it into the abdomen.The contact stated, "i want to say that it was torn in more than one spot" and that he "was using a different grasper than usual.It was a smaller one but don't know if that would have made a difference." the mesh was discarded and another was brought in to complete the case without further issue.There was no injury to the patient.

• Brand Name: 3DMAX
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 8654473
• Report Number: 1213643-2019-04461
• Device Sequence Number: 19394833
• Product Code: FTL
• UDI-Device Identifier: 00801741030772
• UDI-Public: (01)00801741030772
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K081010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2019

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: 09/28/2023
• Device Catalogue Number: 0115322
• Device Lot Number: HUCW0119
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1