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

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PERMACOL PRODUCT MESH, SURGICAL

  • 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
 

SOFRADIM PRODUCTION SAS UNKNOWN PERMACOL PRODUCT MESH, SURGICAL Back to Search Results
Model Number UNKNOWN PERMACOL PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Hematoma (1884); Seroma (2069); Radiation Exposure, Unintended (3164); No Code Available (3191)
Event Date 01/01/2017
Event Type  Injury  
Manufacturer Narrative
Title: utility of a modified components separation for abdominal wall reconstruction in the liver and kidney transplant population source: archives of plastic surgery 2019;46:462-469 vol. 46 / no. 5 / september 2019. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source of study performed from 2011 to 2017, this is a retrospective review of 19 patients who received kidney and/or liver transplantation prior to presenting with an incisional hernia, all hernias were repaired with open component separation technique (cst) with biologic mesh underlay. Complications occurred in six patients (31. 6%) including hematoma, seroma, wound dehiscence, hernia recurrence and abscess in the subcutaneous tissue as detected by computed tomography scan and cultures grew staphylococcus aureus. Utility of a modified components separation for abdominal wall reconstruction in the liver and kidney transplant population : cara k black, elizabeth g zolper, karen k evans 2011 to 2017. September, 2019.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN PERMACOL PRODUCT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer (Section G)
SOFRADIM PRODUCTION SAS
116 avenue du formans
trevoux 01600
FR 01600
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key9707917
MDR Text Key187616922
Report Number9615742-2020-00374
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 02/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PERMACOL PRODUCT
Device Catalogue NumberUNKNOWN PERMACOL PRODUCT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 02/13/2020 Patient Sequence Number: 1
-
-