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

Catalog Number 0117310

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2015

Event Type  malfunction  

Event Description

The following was reported to davol: it was alleged that when the 3d max light left mesh was opened for use in a laparoscopic inguinal hernia repair procedure there was a tear noted in the corner perimeter of the mesh after removal from the package with no damage noted to the outer product box.The surgeon did not want to use the mesh due to the tear and another was used to complete the case without further issue.As reported the device was not used on the patient and there was no patient injury.Based on the allegation of a tear in the mesh, this could compromise the efficiency of the mesh.Therefore this mdr is submitted to document this event.

Manufacturer Narrative

The sample was returned and evaluated.Visual examination confirmed a tear on the lower lateral edge of the mesh.Also noted was what appears to be a stain of dried blood in close proximity to where the tear was located.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 359 units.At this time no definitive conclusion can be made.It is possible that the device was inadvertently damaged during removal from the protective tray.Davol will monitor for trends.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: 3DMAX LIGHT
• Type of Device: FTL
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot#1, road#3, km 79.7; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings blvd; warwick, RI 02886 ; 8005566756
• MDR Report Key: 4828248
• MDR Text Key: 5838241
• Report Number: 1213643-2015-00191
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2015
• 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: 0117310
• Device Lot Number: HUZA0685
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/07/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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
• Patient Age: 36 YR