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

Catalog Number 0117311

Device Problems Device Markings/Labelling Problem (2911); No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2019

Event Type  malfunction  

Manufacturer Narrative

The sample was not returned for review and the information provided is limited. Additional information has been requested. A review of the manufacturing records was performed and found that the lot was manufactured to specification. No manufacturing issues associated to the alleged incorrect packaging were found in the reviewed lot. To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in february 2019. At this time, there is no identification of a problem with the device, however no definitive conclusion can be made as to the cause of the problem reported. Should additional information be provided, a supplemental emdr will be submitted.

Event Description

A customer in (b)(6) alleged that on (b)(6) 2019 a 3dmax light left mesh was opened, "but inside the box it was not the left. " alleged the product was "poorly packed". More details have been requested, but no additional information is available at this time.

• 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: 8758011
• MDR Text Key: 150135998
• Report Number: 1213643-2019-05743
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 0117311
• Device Lot Number: HUCZ1661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial