MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH -VENTRALEX; SURGICAL MESH

Catalog Number 0010301

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

This initial mdr is being submitted as a result of a retrospective review of davol¿s mdr decisions and the initial decision not to report the event is being revised to reflect updated company procedures.Visual examination finds the device in a damaged condition.The pdo ring within the mesh pocket is partially detached and mesh is damaged (torn).Positioning strap has been removed by user based on the sample evaluation this complaint is confirmed.The noted damage is consistent with a handling related issue.It appears that when attempting to suture the mesh after positioning it in place, the device was inadvertently damaged by the user.A review of the manufacturing records was performed and found that the lot was manufactured to specification.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

Alleged "customer reports the ventralex mesh ( 0010301 ; huzg0681 )" shredded into several pieces "when the doctor began suturing the mesh during an umbilical repair.The surgeon removed the pieces and sutured in another ventralex patch without a problem." the umbilical case was being performed in an open fashion with sutures only.Surgeon was not using additional force or unusual technique.No patient injury.

• Brand Name: MESH -VENTRALEX
• 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 6740128
• MDR Text Key: 80943239
• Report Number: 1213643-2017-00430
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(17)190228(10)HUZG0681
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/25/2017

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: 02/28/2019
• Device Catalogue Number: 0010301
• Device Lot Number: HUZG0681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2015
• 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