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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL MESH, SURGICAL

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SOFRADIM PRODUCTION SAS MESH TSL - PERMACOL MESH, SURGICAL Back to Search Results
Model Number UNKNOWN PERMACOL PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Hernia (2240); No Code Available (3191)
Event Date 04/28/2020
Event Type  Injury  
Manufacturer Narrative
Title: outcome after pediatric liver transplantation for staged abdominal wall closure with use of biological mesh¿study with long-term follow-up source: pediatric transplantation. 2020;24:e13683 https://doi. Org/10. 1111/petr. 13683. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature, (year january 2011 to december 2014) this study aimed to assess the outcome of a retrospective study compared the use of abdominal wall closure in pediatric liver transplantation with and without the use of biological mesh. There were 21 patients included in this study, 16 of which utilized biological mesh. Post-operative complications included late-onset abdominal wall infection on the 97th day post-op. During the observation period over 5 years, 2 additional patients developed abdominal wall hernias, one of which required surgical intervention. An additional patient required re-transplantation for chronic allograft failure after 21 months.
 
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Brand NameMESH TSL - PERMACOL
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 Key10809623
MDR Text Key215303179
Report Number9615742-2020-02475
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2020
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/26/2020
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: 11/09/2020 Patient Sequence Number: 1
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