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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 0112950
Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)
Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994); Dysuria (2684)
Event Date 01/27/2020
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 pain, trouble during urinating and infection; however, no details have been provided. A review of the manufacturing records was performed and found that the lot was manufactured to specification. In regards to the infection, the warnings section of the instructions for use (ifu) states "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the mesh. An unresolved infection may require removal of the device. " should additional information be provided, a supplemental emdr will be submitted. Not returned.
 
Event Description
Attorney alleges that the patient was implanted with a bard/davol perfix plug on (b)(6)2019. Attorney alleges that the patient sustained serious personal injuries and damages as a result of the defective device. Attorney alleges that from the date of implant of hernia mesh, the patient has experienced extreme pain, trouble urinating, infections and other ongoing problems as a direct result of the hernia mesh. Attorney also alleges 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 Key12509830
MDR Text Key272582892
Report Number1213643-2021-07613
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number0112950
Device Lot NumberHUBZ1781
Was Device Available for Evaluation? No
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/13/2018
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: 09/21/2021 Patient Sequence Number: 1
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