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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 UNKAA077
Device Problem Migration (4003)
Patient Problems Erosion (1750); Obstruction/Occlusion (2422)
Event Date 06/15/2015
Event Type  Injury  
Manufacturer Narrative

Based on the information extracted from the article, we are unable to determine to what extent, if any, the davol device may have caused or contributed to the patient's postoperative course. At this time no conclusion can be made. A lot number was not provided, as such a review of the manufacturing records cannot be conducted. Should additional information be provided, a supplemental emdr 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

The following was reported via journal article (hernia, aug. 2018, vol. 22 issue 4): title: bowel obstruction secondary to migration of a ventralex mesh: report of a rare complication. Based on the article the patient was treated for a parastomal hernia with intraperitoneal placement of a goretex mesh. Approximately, one year after surgery, he was diagnosed with a small periumbilical incisional hernia. The patient underwent repair with the implantation of a ventralex hernia patch. At six months postoperative he experienced an episode of complete small bowel obstruction which was managed conservatively. The diagnosis of obstructive ileus was established by ct scan and the clinical suspicion of incisional hernia recurrence was verified. Thereafter, he was suffering from bowel obstruction almost once every 2 months. A ct scan revealed recurrence of incisional hernia and small bowel obstruction. The patient underwent a procedure for which extensive adhesiolysis between jejunal loops and the inferior surface of the goretex mesh and the anterior abdominal wall was performed. The mesh (gortex) was excised. During exploration of the peritoneal cavity, they palpated a mobile intraluminal mass in the proximity of splenic flexure. With gradual squeezing of the wall of the colon, they managed to propel out a foreign body through the permanent stoma that was proved to be the ventralex hernia patch (explanted). There was no thickening of the wall of the colon nor were there any signs of fistula between colonic segments and the anterior abdominal wall or the small bowel. The patient was discharged on the fifth postoperative day and 17 months thereafter, he remains in good health.

 
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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 Key7804609
MDR Text Key117852330
Report Number1213643-2018-02859
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeGR
PMA/PMN NumberK132441
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA077
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 Received08/31/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 08/22/2018 Patient Sequence Number: 1
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