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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
Catalog Number 5950008
Device Problem Insufficient Information (3190)
Patient Problems Diarrhea (1811); Pain (1994); Obstruction/Occlusion (2422)
Event Date 09/07/2016
Event Type  Injury  
Manufacturer Narrative

No additional details have been provided. Multiple attempts have been made to obtain additional details of the case, however to date there has been no response. No lot number has been provided; therefore a review of the manufacturing records could not be conducted. Based on the limited information available at this time, no conclusions can be made to the degree to which the bard ventralex hernia patch contributed to the reported post-op complication. Should additional information be obtained, 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. Not returned.

 
Event Description

It was reported that 3 months post implant of a bard ventralex hernia patch the patient experienced a bowel obstruction. No further details available at this time regarding patient condition and treatment. Surgeon has been asked to supply additional information.

 
Manufacturer Narrative

This is an addendum to the initial mdr to document additional information provided. As reported following implant the patient presented with the symptoms of pain, bloating and rectal bleeding, and an mri eliminated small bowel obstruction. The additional information provided states that the patient has a history of pain, bloating and rectal bleeding prior to mesh placement. Additionally, as reported the patient has had no further episodes of possible adhesive obstruction. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Based on the additional information provided at this time, no conclusions can be made to the degree to which the bard device in question may have contributed to the reported post-op complication. Should additional information be obtained, a supplemental mdr will be submitted.

 
Event Description

It was reported that 3 months post implant of a bard ventralex hernia patch the patient experienced a bowel obstruction. No further details available at this time regarding patient condition and treatment. Surgeon has been asked to supply additional information. This is an addendum to the initial mdr as additional information has been provided by the surgeon. On (b)(6) 2016 - patient underwent umbilical hernia repair and was implanted with a bard ventralex st hernia patch. One defect presented and two additional underlying hernia were noted. The hernia patch was placed preperitoneal. The surgeon separated the peritoneal space. The hernia patch was fixated with absorbable pdo sutures. The surgeon notes that the implant presented with normal properties, no problems experienced. On (b)(6) 2016 - patient reported normal post operative pain, during follow up visit. On (b)(6) 2016 - patient presented to the er with abdominal pain, bloating and rectal bleeding. Mri eliminated small bowel obstruction as a cause. On (b)(6) 2017 - patient presented with pain, vomiting, diarrhea and distended abdomen. On (b)(6) 2017 - patient has no further episodes of possible adhesive obstruction, still reports irregular bowel movements.

 
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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
laura berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key6215561
MDR Text Key63635759
Report Number1213643-2016-00594
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK101928
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/28/2017
Device Catalogue Number5950008
Device LOT NumberHUZJ0814
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/30/2015
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: 12/30/2016 Patient Sequence Number: 1
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