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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); Insufficient Information (3190)
Patient Problems Nerve Damage (1979); Hernia (2240); Disability (2371)
Event Date 06/19/2019
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, subsequent surgical intervention, bulging (hernia recurrence), nerve damage and inflammation. The instructions-for-use supplied with the device lists hernia recurrence and inflammation as possible complications. A review of the manufacturing records was performed for the subject lot 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 or about (b)(6) 2014, the patient underwent repair for a right groin hernia and was implanted with a non-bard/davol mesh. On or about (b)(6) 2018, the patient underwent surgery for the repair of recurrent right groin hernia and was implanted with a bard/davol perfix plug. On or about (b)(6) 2019, the patient underwent revision surgery due to the hernia mesh device. It is also alleged that the patient underwent the removal of the non-bard/davol mesh. It is alleged that the patient experienced and/or continues to experience severe and chronic pain/discomfort, inflammation, significant scarring, bulging mass and neurectomy of genital branch of genitofemoral nerve. Attorney alleges general allegations for "past, present, and future damages, including but not limited to, mental and physical pain and suffering for severe and permanent personal injuries sustained by the patient. " 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 Key11378825
MDR Text Key241235899
Report Number1213643-2021-01215
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial
Report Date 02/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/25/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0112760
Device LOT NumberHUBU0907
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/03/2017
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: 02/25/2021 Patient Sequence Number: 1
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