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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH Back to Search Results
Catalog Number UNKAA066
Device Problems Device Damaged by Another Device; Torn Material
Event Date 11/29/2016
Event Type  Malfunction  
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.

 
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.

 
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Brand NameSEPRAMESH IP
Type of DeviceSURGICAL 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 Key6331826
Report Number1213643-2017-00111
Device Sequence Number1
Product CodeFTL
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
0 PatientS WERE Involved in the Event:
Date FDA Received02/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKAA066
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2017
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

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