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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
Model Number 0112750
Device Problems Defective Device (2588); Material Deformation (2976)
Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Disability (2371)
Event Date 12/10/2014
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the post-operative complications experienced by the patient. No sample has been returned for evaluation. Inflammation and allergic reaction are known inherent risks of surgery and are identified in the adverse reaction section of the instructions-for-use as a possible complication. If additional event and/or evaluation information is obtained, a follow up 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 to manufacturer.
 
Event Description
The following was reported to davol by the patient's attorney: it is alleged by the patients attorney that on (b)(6) 2014, the patient underwent surgery for repair of an umbilical hernia and inguinal hernia. As reported, a bard/davol perfix plug, reference number (b)(4), lot number huxj0072 was implanted to repair the inguinal hernia defect. It is alleged that sometime after placement, the device malfunctioned, inter alia, contracting, suffering degradation, and causing an intense foreign body and inflammatory response. It is alleged that as a result of these failures, the patient has suffered severe injuries and required medical care which has consisted of, amongst other things, removal of the defective device on or about (b)(6) 2014. 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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key7154784
MDR Text Key96050800
Report Number1213643-2017-01139
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
Reporter Occupation Attorney
Type of Report Initial
Report Date 12/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/28/2018
Device Model Number0112750
Device Catalogue Number0112750
Device Lot NumberHUXJ0072
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 Received12/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2013
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: 12/29/2017 Patient Sequence Number: 1
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