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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 0010301
Device Problem Insufficient Information (3190)
Patient Problems Pain (1994); Hernia (2240)
Event Date 12/21/2009
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. Based on the limited information provided at this time, no conclusions can be made. As reported it appears the patient experienced multiple internal herniations. 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 obtained, a supplemental emdr will be submitted. Not returned.
 
Event Description
It was reported that on (b)(6) 2005 the patient was implanted with a bard/davol ventralex hernia patch for the repair of a ventral hernia. As reported the patient had complaints of pain following the implant and was diagnosed with a recurrent hernia. It is alleged that on (b)(6) 2009 the patient underwent a laparoscopic repair of a recurrent ventral hernia. Per the contact, the operative dictation indicates there were 3 hernias. One being at the incisional site of the previous repair, one being just below the umbilicus and one smaller hernia in the ventral abdomen. As reported there is no indication the bard/davol ventralex hernia patch was explanted at this time. As reported dual sided "prolene" (non bard/davol) mesh was implanted to repair the umbilical hernia.
 
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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
laura sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7152723
MDR Text Key96005098
Report Number1213643-2017-01127
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K024008
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/28/2010
Device Catalogue Number0010301
Device Lot Number43FPD441
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 Received12/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/28/2005
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: 12/28/2017 Patient Sequence Number: 1
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