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

Catalog Number 0010301

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date there have been no other reported complaints for this manufacturing lot of (b)(4) units released for distribution on 12/04/2016.As reported the sample was discarded by the user facility.Based on not having the sample returned for evaluation, we are unable to confirm the reported product problem or evaluate for root cause.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

It was reported when the operating room staff opened the bard ventralex hernia patch package for use, the mesh ring was noted to have been detached from the mesh.Contact stated this was noted as the mesh was laying flat and there was no manipulation of the mesh or ring.Another bard ventralex hernia patch was opened with no further issue.The device is question was discarded by the user facility and therefore not available for sample evaluation.There was no injury to the patient.

• 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6552524
• MDR Text Key: 74683528
• Report Number: 1213643-2017-00292
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(17)200528(10)HUAY0126
• 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: Other
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2020
• Device Catalogue Number: 0010301
• Device Lot Number: HUAY0126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2016
• 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