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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 0010303
Device Problem Migration or Expulsion of Device
Event Date 06/15/2015
Event Type  Injury  
Event Description

The following was reported to davol: (b)(6) 2012 - the patient underwent ventral hernia repair and was implanted with a bard ventralex hernia patch. On (b)(6) 2013 - the patient had a ¿feeling the ventralex patch move to the right" and he experienced chronic abdominal pain and discomfort. On (b)(6) 2015 - during an annual work related physical for the dept. Of transportation the patient was diagnosed with a large recurrent abdominal hernia and was told he needed to have it repaired. It is reported that for several months multiple doctors have told the patient that the patch needs to be removed and the recurrent hernia repaired. Also reported is the patient has had multiple bowel blockages, rectal bleeding, difficulty breathing due to the size of the recurrent hernia pressing against his lungs and abdominal pain since implant of the ventralex hernia patch. The patient indicated that at this time he has not scheduled a date for his hernia repair surgery.

 
Manufacturer Narrative

A review of the manufacturing records was performed and found that the lot was manufactured to specification. Recurrence is a known inherent risk of the surgery and is listed in the adverse reaction section of the ifu as a possible complication. Additionally, the warning section recommends, to prevent recurrences that the prosthesis should be large enough to extend beyond the margins of the defect and to ensure a strong repair, the prosthesis should be secured with tack or sutures through the polypropylene mesh straps or positioning pocket. Based on the information provided no conclusion can be made as to the degree to which the implant may have caused or contributed to the patient¿s reported post implant experience. As reported a revision procedure has been recommended by the patient's doctors; however at this time there has been no surgical intervention, nor has a revision date been scheduled. Should additional information be provided, a supplemental 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. Remains implanted.

 
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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 berg
100 crossings blvd.
warwick , RI 02886
4018258462
MDR Report Key6675252
Report Number1213643-2017-00374
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation Other
Type of Report Initial
Report Date 06/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/28/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/28/2016
Device Catalogue Number0010303
Device LOT NumberHUVJ0345
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 Received06/08/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/29/2011
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: 06/28/2017 Patient Sequence Number: 1
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