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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUG SURGICAL MESH Back to Search Results
Catalog Number 0112760
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative

Based on the information available at this time, no conclusions can be made. Recurrence is listed in the adverse reaction section of the ifu as a possible complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. If additional information is provided, a supplemental mdr will be submitted. Note: 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. Remains implanted.

 
Event Description

The following was reported to davol and is not based on medical documentation: on (b)(6) 2013 - the patient was diagnosed with a right inguinal hernia and underwent repair with implant of a bard perfix plug. Ni/ni/2013 - the patient had an md office follow up exam and the surgeon removed the staples. During this procedure the surgeon decided to add an additional staple to the patient's wound. On (b)(6) 2014 - the patient had an md office exam with complaints of severe pain and a right inguinal bulge. The surgeon indicated there appears to be a recurrence of the hernia and the patient would most likely need additional surgery. The patient did not want to follow through with an additional procedure. The patient was prescribed narcotic pain medication to help relieve the pain. Ni/ni/2015 - the patient continued to experience pain and was treated at a rehabilitation facility due to a dependence on narcotic pain medication and addiction to non prescribed pain medication and/or illicit drugs. The patient was prescribed suboxone to help manage the pain and addiction to long term use of narcotic pain medication and continues to follow up with a primary care physician to help manage the pain. The patient does not want to follow up with a surgeon or have any additional surgical intervention performed at this time.

 
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Brand NamePERFIX 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 Key6212201
MDR Text Key63480887
Report Number1213643-2016-00592
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
PMA/PMN NumberK922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 12/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/30/2018
Device Catalogue Number0112760
Device LOT NumberHUXD0736
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/20/2013
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: 12/29/2016 Patient Sequence Number: 1
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