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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. VENTRALEX ST SURGICAL MESH Back to Search Results
Model Number 5950007
Device Problem Defective Device (2588)
Patient Problems Pain (1994); Hernia (2240); Disability (2371)
Event Date 05/19/2017
Event Type  Injury  
Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. Based on the information provided, the patient experienced hernia recurrence. Recurrence is a known inherent risk of hernia repair surgery and is 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. Not returned to manufacturer.

 
Event Description

The following was reported to davol by the patient's attorney: (b)(6) 2015 - the patient underwent surgery for repair of an umbilical hernia, a ventralex st mesh was implanted to repair the hernia defect. (b)(6) 2015 - the patient underwent an additional surgery to repair the hernia defect and remove it. At that time a non-bard davol mesh was implanted and the previous ventralex mesh was partially excised. (b)(6) 2017 - the patient underwent an additional surgery to repair the hernia defect and remove it. At that time, both prior meshes were removed , along with a partial resection of the abdominal wall. New biologic mesh was placed. The attorney alleges the patient has suffered and will continue to suffer pain, and was injured severely and permanently.

 
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Brand NameVENTRALEX ST
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 Key7140314
MDR Text Key95590644
Report Number1213643-2017-01094
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation ATTORNEY
Type of Report Initial,Followup
Report Date 04/26/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2016
Device MODEL Number5950007
Device Catalogue Number5950007
Device LOT NumberHUYG1070
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 Received04/25/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/26/2014
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: 12/21/2017 Patient Sequence Number: 1
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