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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 Necrosis (1971); Seroma (2069); Hernia (2240); Post Operative Wound Infection (2446)
Event Date 04/12/2020
Event Type  Injury  
Manufacturer Narrative
Title: case¿control comparison of separation of component retrorectus urinary bladder extracellular surgical device hernia repair with acellular dermal matrix underlay and prosthetic mesh overlay hernia repair. Source: international journal of abdominal wall and hernia surgery 2021;4:13-9. Published: 22-02-2021. If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the literature source of study performed between may 1, 2012 and may 31, 2019, outcomes of patients who underwent two types of incisional hernia repairs were compared. One technique was the sandwich biologic mesh underlay/synthetic mesh overlay (buso) repair technique; the second technique was separation of components with retrorectus mesh (socrm). There were 28 patients in each group and complications included: superficial skin necrosis, superficial wound infection, hernia recurrence and seroma. Re-operation was required for hernia recurrence. Superficial surgical site infection and necrosis required antibiotics, bedside debridement or drainage of the infection. Seroma was treated with aspiration. Three patients required either ¿home health¿ assistance or placement at a skilled nursing.
 
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Brand NameUNKNOWN 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 Key12229281
MDR Text Key263575026
Report Number9615742-2021-01813
Device Sequence Number1
Product Code FTL
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 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX PRODUCT
Device Catalogue NumberUNKNOWN PARIETEX 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 Received07/06/2021
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: 07/27/2021 Patient Sequence Number: 1
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