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

Catalog Number 0115320

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/03/2015

Event Type  malfunction  

Event Description

The following was reported to davol: it was reported that during an inguinal repair procedure using a 3dmax mesh device, the mesh was rolled using a grasper and inserted through a 10mm port.When the mesh was unrolled inside the body cavity the surgeon noted the mesh was torn and damaged in placement.The mesh was removed and another 3dmax mesh was used to complete the case without issue.There was no injury to the patient.

Manufacturer Narrative

The sample was returned and evaluated.Visual examination confirmed tears on the lower sealed edge of the mesh.A manufacturing review was performed and found that the lot was manufactured to specification with no discrepancy.There have been no other complaints reported to date for this manufacturing lot of (b)(4) units.Based on the information provided and the results of this investigation, the damage observed was sustained during the placement of the mesh, likely due to interface with other devices used.The information provided by bard 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 bard.

• Brand Name: 3DMAX MESH
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: steven figueroa ; 100 crossings blvd.; warwick, RI 02886 ; 4018258460
• MDR Report Key: 4950253
• MDR Text Key: 18637054
• Report Number: 1213643-2015-00264
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K081010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 0115320
• Device Lot Number: HUYL0463
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1