• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH Back to Search Results
Catalog Number 5959124
Device Problem Insufficient Information
Event Date 01/04/2016
Event Type  Injury  
Manufacturer Narrative

As reported this is a patient with a complex medical/surgical history significant for acute biliary pancreatitis, acute respiratory distress syndrome, abscesses, prolonged intubation tracheotomy, cholecystectomy, small bowel resection, surgical washings (7), a partial pancreatectomy (25%) and diagnosed with the presence of a controlled ventral hernia, all occurring in 2012. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Adhesion is a known inherent risk and is identified in the adverse reaction section of the ifu as a possible complication. Regarding infection the ifu states, "if an infection develops, treat the infection aggressively. Consideration should be given regarding the need to remove the prosthesis. An unresolved infection may require removal of the prosthesis. " at this time, no conclusion can be made as to the degree to which the mesh implant may have caused or contributed to the patient outcome. If additional information is 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.

 
Event Description

The following was reported to davol: on (b)(6) 2014 - repair of a ventral hernia with the placement of a sepramesh ip. On (b)(6) 2014 - presented with persistent abdominal pain and increased symptomatology. On (b)(6) 2015 - exploratory laparotomy was performed. (results not provided). On (b)(6) 2016 - presented with draining gastro-intestinal, tachycardia and fever. On (b)(6) 2016 - exploratory laparotomy. A frozen abdomen was observed and two perforations in the small intestine in the presence of the mesh adhered to the intestine. The mesh was removed, a surgical washing was performed, the perforations were repaired and a bogata bag was placed. On (b)(6) 2016 - the patient underwent a surgical washing and the placement of a vac system with dehiscence of repair. The patient is currently in the intensive care with an open abdomen.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSEPRAMESH IP
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 Key5393032
Report Number1213643-2016-00022
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation PHYSICIST
Type of Report Initial
Report Date 01/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2016
Device Catalogue Number5959124
Device LOT NumberHUXG1312
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/11/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/31/2013
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: 01/27/2016 Patient Sequence Number: 1
-
-