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

Catalog Number 5950040

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2016

Event Type  malfunction  

Manufacturer Narrative

As reported the "coating peeled off of the mesh." it is reported that the sample is being returned for evaluation; however has not been received to date.At this time no conclusions can be made.A manufacturing review is underway and upon return, the sample will be evaluated.When these activities have been completed a supplemental mdr will be submitted.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

The following was reported to davol.It is reported that the "coating was peeling off of the mesh (ventrio st)." another mesh was used to complete procedure without further issue.There was no injury to the patient.

Manufacturer Narrative

The sample was returned for evaluation and is confirmed for having some material separation of the st coating.The returned sample was hydrated and the st layer became tacky as it would during proper hydration and was not peeling off.This was not reported as an out of the box condition.Based on the product evaluation and available information we are unable to determine the cause for the coating to have peeled off of the mesh.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in june, 2016.A review of the manufacturing records was performed and found that the lot was manufactured to specification.Updated: report date, model #/lot #, device available for evaluation?, date received by mfr?, type of reports, if follow-up, what type?, device evaluated by mfr?, device manufacture date, evaluation codes, additional mfr narrative.

• Brand Name: VENTRIO ST
• 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: 6121973
• MDR Text Key: 60764197
• Report Number: 1213643-2016-00531
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101920
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Catalogue Number: 5950040
• Device Lot Number: HUAR0811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2016
• 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