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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 0112970
Device Problems Device Issue (2379); Defective Device (2588)
Patient Problems Pain (1994); Hernia (2240); Disability (2371)
Event Date 12/07/2010
Event Type  Injury  
Manufacturer Narrative

To date, limited information has been provided. Based on the information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged. Hernia recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication. If additional information is obtained, a supplemental mdr will be submitted. 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. Not returned.

 
Event Description

It is alleged by the patients attorney that on (b)(6) 2010, the patient underwent surgery for repair of an incarcerated left inguinal hernia. As reported, a bard/davol perfix plug, reference number 0112970, lot number huta0663 was implanted to repair the hernia defect. It is alleged that on (b)(6) 2010, the patient underwent an additional surgery to repair recurrent hernia after the perfix plug failed and to remove the perfix plug. As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective perfix plug.

 
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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
jessica messier
100 crossings blvd.
warwick, RI 02886
4018258720
MDR Report Key7268439
MDR Text Key99983843
Report Number1213643-2018-00278
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 ATTORNEY
Type of Report Initial
Report Date 02/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/28/2014
Device Catalogue Number0112970
Device LOT NumberHUTA0663
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 Received01/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/23/2009
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: 02/13/2018 Patient Sequence Number: 1
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