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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 Problems Defective Device (2588); Patient Device Interaction Problem (4001)
Patient Problems Granuloma (1876); Pain (1994); Hernia (2240)
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including permanent injury, hernia recurrence, granuloma and surgical intervention. The instructions-for-use (ifu) supplied with the device lists recurrence of the hernia as a possible complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Should additional information be provided, a supplemental emdr will be submitted. Not returned.
 
Event Description
Attorney alleges that on (b)(6) 2011, the patient underwent surgery for an inguinal hernia repair surgery and a bard/davol perfix plug was implanted. Attorney also alleges that further to implantation with the product, the patient suffered with the development of suture granuloma and hernia recurrence. It is alleged that the patient has suffered injuries, losses and damages resulting from numerous defects in the product that create an unreasonably high risk of injury with severe permanent adverse health consequences. Attorney alleges that the patient experienced severe pain and suffering, including chronic pain. It is also alleged the patient was treated with a course of hospitalization, diagnostic imaging, revision surgery, serum testing, antibiotics, analgesics and rest. Attorney alleges that the patient will require further invasive repair surgery, physiotherapy, rehabilitation and will continue to require other forms of medical care. It is also alleged that the device was defective.
 
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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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
4018258495
MDR Report Key12322191
MDR Text Key266590042
Report Number1213643-2021-06871
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
Type of Report Initial
Report Date 08/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/28/2015
Device Catalogue Number0112760
Device Lot NumberHUTK2038
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/20/2010
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: 08/14/2021 Patient Sequence Number: 1
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