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

Catalog Number 0117311

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

Patient Problem No Patient Involvement (2645)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

The information provided is limited, and it is unclear what the reporter means by "broken". As reported, the mesh is available for return, however, to date the sample has not been received at davol. Multiple attempts have been made to request additional information, including the return of the sample for evaluation. At this time there has been no response. 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 299 units released for distribution in july 2018. Should additional information be obtained and/or the sample returned for evaluation, a supplemental emdr will be submitted. Not returned.

Event Description

As reported,when the surgeon opened the 3dmax light mesh on (b)(6) 2019, he found the mesh was "broken" inside package. The mesh was not used in the case. As reported, the sample is being 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 8753795
• MDR Text Key: 149812620
• Report Number: 1213643-2019-05694
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/28/2020
• Device Catalogue Number: 0117311
• Device Lot Number: HUCT0124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/02/2019 Patient Sequence Number: 1