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

Catalog Number 0010301

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2017

Event Type  malfunction  

Manufacturer Narrative

Based on not having a sample to evaluate, we are unable to determine a root cause for the reported issue experienced by the surgeon.As reported there was no injury to the patient.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in (b)(6) 2017.The emdr represents patch #2 an additional emdr was submitted to document information associated with patch #1 note: 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.Not returned.

Event Description

As reported on (b)(6) 2017 during an open umbilical hernia repair procedure the surgeon noticed, after handling and placing a bard ventralex hernia patch (#1) into the patient that the stitching attaching the eptfe to the polypropylene patch was ¿loose¿ or coming undone.The patch was not implanted and another bard ventralex hernia patch (#2) was opened.After handling and placing the bard ventralex hernia patch into the patient the surgeon noted the same issue and elected not to use the patch.Another bard ventralex hernia patch was opened and used without issue.The patches were discarded by the facility.As reported the surgeon is an experienced user of the bard ventralex hernia patch.

Manufacturer Narrative

This is an addendum to the initial emdr to document a correction to (device manufacture date) and to also document the results of the manufacturing review.The review found that the lot was manufactured to specification with no anomalies noted.

• 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 sundberg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 7118640
• MDR Text Key: 95754853
• Report Number: 1213643-2017-01030
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741000355
• UDI-Public: (01)00801741000355
• Combination Product (y/n): N
• PMA/PMN Number: K132441
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2020
• Device Catalogue Number: 0010301
• Device Lot Number: HUBN1005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2017
• 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