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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. MESH - VENTRALEX SURGICAL MESH Back to Search Results
Catalog Number 0010302
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Pain (1994); Hernia (2240); Disability (2371)
Event Date 07/26/2017
Event Type  Injury  
Manufacturer Narrative

There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. The sample was not returned for evaluation. Based on the limited information provided at this time, no conclusions can be made. 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. Should additional information be provided a supplemental emdr will be submitted. Not returned.

 
Event Description

The following was alleged by the patient's attorney: (b)(6) 2015: the patient underwent surgery for repair of an incisional hernia. A bard/davol ventralex hernia patch mesh, (b)(4), lot number huze0905 was implanted to repair the hernia defect. (b)(6) 2017: the patient underwent an additional surgery to remove mesh and repair the incisional hernia. As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex hernia patch.

 
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Brand NameMESH - VENTRALEX
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
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key7155227
MDR Text Key96062777
Report Number1213643-2017-01147
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132441
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 HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2018
Device Catalogue Number0010302
Device LOT NumberHUZE0905
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 Manufactured07/15/2015
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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