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 Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

The most probable root cause is the mesh was damaged during use.Visual evaluation of the sample finds that the mesh has been folded/rolled prior to attempted implantation.The section of the edge seal that is frayed/cracked corresponds with a fold line in the mesh.Based on the event as reported and sample condition, the fraying/cracking of the edge seal condition found, inadvertently occurred during user/device interface while attempting to deploy the mesh.A review of the manufacturing records was performed and found that the lot was manufactured to specification.

Event Description

It was reported that on (b)(6) 2019 the bard 3dmax light mesh was noted to be damaged.Another 3dmax light mesh was used to complete the case.There was no patient injury reported.

• 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: 8912732
• MDR Text Key: 155026818
• Report Number: 1213643-2019-07236
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741031038
• UDI-Public: (01)00801741031038
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: 0117311
• Device Lot Number: HUDQ0653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2019
• 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