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

Catalog Number 0117311

Device Problems Shelf Life Exceeded (1567); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

As reported the expired device was implanted in error. Our review shows that the lot was distributed prior to the expiration date. The product is packaged with the expiration clearly displayed on each level of packaging. The ifu instructs the user to inspect the package prior to use. This event is confirmed to be solely a use related error. Remains implanted.

Event Description

It was reported that on (b)(6) 2017 a 3dmax light mesh with an expiration date of 11/28/2017 was inadvertently implanted into the patient. To date there has been no reported intervention or injury to the patient. The contact was informed that if the packaging was not opened or damaged prior to implant the mesh would be anticipated to be sterile.

• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7165252
• MDR Text Key: 96638757
• Report Number: 1213643-2018-00016
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/04/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2017
• Device Catalogue Number: 0117311
• Device Lot Number: HUWJ2080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial