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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 01/08/2020
Event Type  Death  
Manufacturer Narrative
Title perioperative complications of complex abdominal wall reconstruction with biologic mesh: a pooled retrospective cohort analysis of 220 patients from two academic centers source international journal of surgery, volume 74, 2020 (94¿99) date of publication: 28 december 2019. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source of study performed aimed to identify perioperative predictors of outcomes after complex abdominal wall reconstruction (cawr) with biologic mesh (bm). In this retrospective study, perioperative complications were analyzed in all patients who underwent open cawr with bm over six years in two academic centers. There were 220 patients included in the study and 8 were implanted with the company's complication. 8 patient death occurred during the study. The reasons for patient death were not reported. Which mesh was used in the reported adverse events was not reported.
 
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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 Key9889085
MDR Text Key185245923
Report Number9615742-2020-00701
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 health professional,literatur
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-PERMACOL
Device Catalogue NumberUNKNOWN-PERMACOL
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 Received03/05/2020
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: 03/27/2020 Patient Sequence Number: 1
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