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

Catalog Number 0117321

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

The sample was returned and evaluated.The evaluation finds blood visible on the mesh which is consisted with the mesh having been inserted into the patient as reported.The evaluation found three breaks in the bottom edge seal and notes the mesh, in two of those areas was beginning to tear.The mesh had evidence of having been folded and two of the three breaks in the bottom edge seal were at the location of the fold.The evaluation also noted pulls in the mesh material.As reported this was not an out of the box condition and was only found after manipulation of the mesh.It is possible the user inadvertently damaged the mesh while manipulating before implantation.However, a definitive cause is unknown at this time.To date this is the only reported complaint for this manufacturing lot of 348 units released for distribution on 11/07/2016.A review of the manufacturing records was performed and found that the lot was manufactured to specification with no anomalies 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.

Event Description

It was reported that after inserting the 3dmax mesh into the patient, the surgeon noted torn mesh on the bottom edge of the device in two locations.There was no injury to the patient and the case was completed with another bard 3dmax mesh.The sample was returned for evaluation.

• Brand Name: 3DMAX LIGHT
• 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6483016
• MDR Text Key: 72519649
• Report Number: 1213643-2017-00230
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031069
• UDI-Public: (01)00801741031069(17)211028(10)HUAX0144
• Combination Product (y/n): N
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: 0117321
• Device Lot Number: HUAX0144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• 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