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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX LIGHT PLUG SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. PERFIX LIGHT PLUG SURGICAL MESH Back to Search Results
Catalog Number 0117080
Device Problems Unsealed Device Packaging (1444); Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The samples are expected to be returned for evaluation, however have not been received to date. A review of the manufacturing records was performed and found that the lot (269 units) was manufactured to specification, with no anomalies noted. No other complaints have been reported to date for this lot. When the samples are returned a supplemental mdr will be sent to document our findings.
 
Event Description
It was reported to bard/davol by our (b)(6) affiliate that during their incoming inspection two perfix light plugs were identified as having a possible insufficient seal. The units are being returned for evaluation. As a possible breach of sterile barrier condition was alleged to be present an mdr is being filed to document the condition reported.
 
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Brand NamePERFIX LIGHT PLUG
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 Key6166335
MDR Text Key62355072
Report Number1213643-2016-00569
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K092032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial
Report Date 12/12/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2021
Device Catalogue Number0117080
Device Lot NumberHUAT2532
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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