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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 0112980
Device Problems Defective Device (2588); Material Protrusion/Extrusion (2979); Insufficient Information (3190); Patient Device Interaction Problem (4001); Migration (4003)
Patient Problems Nerve Damage (1979); Seroma (2069); Hernia (2240); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided a supplemental emdr will be submitted.Not returned.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol perfix plug on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the perfix plug.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.
 
Manufacturer Narrative
At this time no conclusions can be made.The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this is an addendum to the initial emdr submitted.This supplemental emdr is submitted to report the additional event details and product identifiers received.As alleged, the patient experienced multiple complications post-implant of the bard perfix plug.This additional information does not change the initial determination, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in may 2007.Seroma, hernia recurrence, adhesions, extrusion and inflammation are listed as possible complications in the adverse reactions section of the instructions for use (ifu) supplied with the device.Should additional information be provided, a supplemental emdr will be submitted.Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of an unspecified bard/davol perfix plug on (b)(6) 2007.As reported, the patient is making a claim for an adverse patient outcome against the perfix plug.Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device.It is also alleged that the patient experienced emotional distress and the device was defective.Addendum : as reported, the patient experienced symptoms of seroma, neuromas, adhesion to the spermatic cord, inflammation, extrusion, recurrence of the groin hernia, incarcerated fat herniation, severe stage four varicocele, swollen groin, swollen testicle, swollen lymph nodes, disconnected from the peritoneum, mesh migration, mesh failure, pain on the groin area, left leg numbness post-implant of a bard/davol perfix plug in 2007.
 
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Brand Name
PERFIX PLUG
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key10008354
MDR Text Key189592322
Report Number1213643-2020-04159
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date05/28/2012
Device Catalogue Number0112980
Device Lot NumberHURD0828
Was Device Available for Evaluation? No
Date Manufacturer Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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