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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117080
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2020
Event Type  malfunction  
Manufacturer Narrative
At this time, no conclusion can be made. While the sample evaluation is anticipated it has not get begun. When the investigation has been completed, a supplemental emdr will be submitted.
 
Event Description
As reported, it was identified that after opening the perfix light plug package on (b)(6) 2020, a foreign material like filamentous polypropylene was found on the plug. There was no reported patient injury and the patient did not have infection at the time of implant.
 
Manufacturer Narrative
At this time, no conclusion can be made. While the sample evaluation is anticipated it has not yet begun. Addendum: this is an addendum to the initial mdr submitted. This supplemental mdr is submitted to report the results of the device evaluation. As reported, it was identified that after opening the package a foreign material like filamentous polypropylene was found on the plug. The subject device was returned for evaluation. Visual evaluation of the returned material confirmed to be a piece of the monofilament used when stitching the petals together. There was no alleged detachment of the plugs during use indicating that the material found is residual from the manufacturing process likely from the when the thread was cut. Based on sample evaluation and investigation performed, the reported event was confirmed and the root cause was determined to be manufacturing related. Review of manufacturing records indicate product was manufactured to specification. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in december, 2019.
 
Event Description
As reported, it was identified that after opening the perfix light plug package on (b)(6) 2020, a foreign material like filamentous polypropylene was found on the plug. There was no reported patient injury and the patient did not have infection at the time of implant.
 
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Brand NamePERFIX PLUG LIGHT
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
8005566756
MDR Report Key10753989
MDR Text Key213614208
Report Number1213643-2020-20024
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117080
Device Lot NumberHUDX2666
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/29/2020 Patient Sequence Number: 1
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