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

Catalog Number UNKAA066

Device Problems Device Damaged by Another Device (2915); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2016

Event Type  malfunction  

Manufacturer Narrative

The sepramesh ip device is a device with an adhesion barrier (hydrogel coating).As reported the mesh was torn during the procedure, and left implanted, although no patient injury has been reported, this condition could compromise the ability of the device to perform as intended posing a potential incremental risk to the patient, as such an mdr is filed to document this event.As reported the damage to the sepramesh ip occurred while the user was attempting to fixate the optifix fixation device into bone.Product identifiers have been requested, however to date have not been provided.At this time a review of the manufacturing records is not possible.Should the requested information be provided a supplemental mdr will be submitted.This file represents the sepramesh ip.An additional mdr has been submitted to represent the optifix fixation device.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.Patient details are unobtainable due to the privacy laws in (b)(6).Remains implanted.

Event Description

Information as reported by the user facility: it was reported that during an inguinal case using an optifix fixation device with a sepramesh ip hernia mesh the user was trying to fixate into bone when the optifix got stuck in the mesh causing the mesh to tear.As reported the sepramesh ip was used to complete the repair; the mesh was fixated with another tacker with no issue.

• Brand Name: SEPRAMESH IP
• 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: 6331826
• MDR Text Key: 67544480
• Report Number: 1213643-2017-00111
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063739
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• 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