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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PRODUCT Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Seroma (2069)
Event Date 07/14/2020
Event Type  Injury  
Manufacturer Narrative
Title: total endoscopic-assisted linea alba reconstruction (teslar) for treatment of umbilical/paraumbilical hernia and rectus abdominus diastasis is associated with unacceptable persistent seroma formation: a single centre experience source: hernia (2020) 24:1379¿1385 https://doi.Org/10.1007/s10029-020-02266-8 received: 20 may 2020 / accepted: 14 july 2020 / published online: 20 july 2020 © springer-verlag france sas, part of springer nature 2020.If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source of study performed between march 2018 and may 2019, total endoscopic-assisted linea alba reconstruction was performed to 21 patients and parietex was used to 3 patients.The aim of the study was to establish the risks and benefits of safely performing total endoscopic-assisted linea alba reconstruction.One patient suffered from severe postoperative infected collection following the procedure which required formal washout and removal of the mesh.Other postoperative complications include: seroma, chronic pain, and recurrence.Patients with seromas underwent aspirations and reoperation.
 
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Brand Name
UNKNOWN PARIETEX PRODUCT
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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key11891751
MDR Text Key252885436
Report Number9615742-2021-01392
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other
Type of Report Initial
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX PRODUCT
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/04/2021
Initial Date FDA Received05/27/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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