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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 UNKAA053
Device Problems Defective Device; Insufficient Information
Event Date 04/17/2015
Event Type  Injury  
Manufacturer Narrative

Based on the information provided it appears the patient was treated with two unspecified perfix plug for bilateral inguinal hernia repairs and a non-bard davol mesh for an umbilical hernia repair. This file represents the left sided hernia repair device. At this time general allegations were made against all "products" implanted in the patient. There are no specific interventions alleged related to the left inguinal hernia repair device. To date no medical records have been provided. Without a lot number a review of the manufacturing records could not be conducted. With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to any post op complications. Another file was created to address the right sided hernia repair product. 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: on (b)(6) 2008 - the patient was diagnosed with left and right inguinal hernia and umbilical hernia. The patient underwent a repair of the hernias with mesh, plug and patch technique. During the operation, the patient was implanted with mesh (covidien parietex) and unspecified bard/davol perfix plug (x2). On (b)(6) 2015 - the patient was diagnosed with recurrent right inguinal hernia. Patient underwent repair of recurrence right inguinal hernia, incarcerated with mesh. The attorney alleges the patient experienced defective mesh, permanent injury, abdominal pain, swelling, ambulation difficulty and additional surgical procedures.

 
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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 Key6568932
Report Number1213643-2017-00310
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 05/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA053
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 Received04/25/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/16/2017 Patient Sequence Number: 1
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