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

Catalog Number 5954680

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

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 review of the manufacturing records was performed and found that the lot was manufactured to specification.If/when the sample is returned a supplemental mdr will be sent to document out findings.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 that the surgeon was using a bard ventralight st hernia patch for a laparoscopic procedure.As reported the patch was hydrated for 1-2 seconds in a saline solution and was then inserted into a 10 mm port.It is reported the patch went down the port and the hydrogel came off on the surgeons hands.Another device was used to complete the case.There was no injury to the patient.

Manufacturer Narrative

This is an addendum to the initial mdr as the sample was returned and the evaluation has been completed.The sample evaluation confirms that the mesh side of the patch was intact with no anomalies.The hydrogel side of the patch is confirmed for material separation of the hydrogel coating.As reported the patch was hydrated 1-2 seconds prior to rolling and inserting down the port, no anomalies were noted at this time by the user.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in september, 2016.The reported event could not be confirmed to be manufacturing related and appears that the problem presented due to user / device interaction.

• Brand Name: VENTRALIGHT ST MESH
• 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: 6286974
• MDR Text Key: 66070221
• Report Number: 1213643-2017-00046
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K101851
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2017

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: 08/28/2018
• Device Catalogue Number: 5954680
• Device Lot Number: HUAU1355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 01/30/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2016
• 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
• Patient Age: 61 YR
• Patient Weight: 77