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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 0117050
Device Problem Material Deformation (2976)
Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994)
Event Date 12/02/2016
Event Type  Injury  
Manufacturer Narrative

As reported, the patient alleged chronic pain, meshoma, internal bleeding and cutaneous femoral nerve post implant of perfix light plug. As reported no additional information will be forthcoming. Based on the information provided, no conclusion can be made as to the degree to which the device, may be causing or contributing the patient¿s reported postoperative symptoms. The instructions-for-use supplied with the device lists pain as a possible complication. This is the only reported complaint to date for the reported lot number. This emdr represents the bard/davol perfix plug light (device #2). An additional emdr was submitted to represent the bard/davol perfix plug light (device #1). Should additional information, a supplemental mdr will be submitted. 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

The following was reported via tga report (australia fda): as reported the complaint cites the use of two perfix light plugs. The tga report states, "i went to see a surgeon regarding right hand side pain, i did a dye ct test and a small inguinal sac was found on the left. I went in to have the hernia repair done, i had 2 plugs put in and a large mesh on a genital femoral hernia that was not detected on dye ct scan. Patient outcome/consequences: cutaneous femoral nerve, meshoma, internal bleeding [redacted] was surprised i lasted as long as i did. After removing the mesh to the genital femoral area there was no hernia found. I have ongoing chronic pain which seen a neurostimulator was placed in my back. I have lost my dysfunctional in my sex life. Recently i have started coming down to with crps, i am due to have a ketamine infusion to lessen the pain. The mesh that was put in place did not need to be there, also this mesh has caused me chronic pain and now i am suffering crps. ".

 
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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 Key11148167
MDR Text Key226093109
Report Number1213643-2020-20096
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK092032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 12/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2021
Device Catalogue Number0117050
Device LOT NumberHUAT1772
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
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 TREATMENT DATA
Date Received: 01/11/2021 Patient Sequence Number: 1
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