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

Catalog Number 0010301

Device Problems Material Frayed (1262); Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/03/2016

Event Type  malfunction  

Manufacturer Narrative

It was reported that the mesh straps came loose from the mesh.The device was not used, another device was used to complete the repair.The sample was returned to davol for evaluation.The pdo ring was not returned with the sample.The straps were attached to the sample with minor fraying noted, there were grasper marks seen on the eptfe.Stitch holes were present as well as a piece of monofilament, evidence of the inner sew line being present.It appears that forces applied during deployment were sufficient to separate the monofilament resulting in material separation of the mesh layers resulting in the separation of the pdo ring from the device.Based on the sample evaluation it appears that when attempting to position the device, forces applied by the user inadvertently caused damaged to the device.This is the only reported complaint for this manufacturing lot of 264 units.

Event Description

It was reported that the mesh straps get loose from the mesh and the straps were disintegrated.It was not possible to use the product.Another device has been placed on 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 4018258495
• MDR Report Key: 6745788
• MDR Text Key: 81147952
• Report Number: 1213643-2017-00457
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355(17)190828(10)HUAN1560
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K024008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/26/2017

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: 08/28/2019
• Device Catalogue Number: 0010301
• Device Lot Number: HUAN1560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 44 YR
• Patient Weight: 52