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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 Foreign Body Reaction (1868); Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Seroma (2069); Hernia (2240); Peritonitis (2252); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446); Bowel Perforation (2668); Unspecified Tissue Injury (4559); Unintended Radiation Exposure (4565)
Event Date 07/12/2021
Event Type  Injury  
Manufacturer Narrative
Title: laparoscopic treatment of incisional and ventral hernia source: society of laparoscopic <(>&<)> robotic surgeons. Published by the society of laparoscopic <(>&<)> robotic surgeons, doi: 10. 4293/js ls. 2021. 00007 april-june 2021 volume 25 issue. 2 (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source of study performed between january 1, 2001 and december 31, 2017, a retrospective study evaluated outcomes of patients who underwent laparoscopic repair of abdominal wall or incisional hernia using the laparoscopic intraperitoneal onlay mesh technique, in all cases, the procedures were approached laparoscopically, the composite mesh was used and fixed in place with either absorbable tacks on 256 patients, titanium tacks on 1383 patients and sutures or fibrin glue on 29 patients. There were 1777 patients in the study and complications included: intraoperative bleeding and bowel perforation, seroma, hematoma, mesh infection, bowel occlusion, peritonitis and hernia recurrence. Conversion to open and reoperations were reported. Patients with mesh bulging underwent ct scan for diagnoses and reoperation for recurrence. Postoperative pain was measured through both a vrs (verbal rating scale) and an nrs (numeric rating scale). With the vrs score, postoperative pain was absent in 21. 2% of patients, mild in 59. 5%, moderate in 18. 9% and severe in 0. 5%. Using nrs categories, patients reported no pain in 20. 4% of cases, mild in 61. 2%, moderate in 18. 0% and severe in 0. 5%. The median length of hospital stay was 2 days.
 
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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 Key12447246
MDR Text Key270549770
Report Number9615742-2021-02171
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2021
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2021
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: 09/09/2021 Patient Sequence Number: 1
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