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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PROGRIP MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX PROGRIP MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PROGRIP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Post Operative Wound Infection (2446)
Event Date 02/19/2021
Event Type  Injury  
Manufacturer Narrative
Title: outcome of open inguinal hernia repair using sutureless self-gripping mesh ¿ a retrospective single cohort study. Source: swiss medical weekly. 2021;151:w20455. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to literature source, a study was performed between 1st of october 2010 and 31st of january 2021 on 162 patients who underwent open inguinal hernia repair using sutureless self-gripping mesh (157 had unilateral inguinal hernia and 5 had bilateral hernia). Reported complications were hernia recurrence (5 patients), hematoma (2 patients), and surgical site infection. Reoperations for 6 patients were required for recurrence and hematoma. The infection was treated with antibiotics.
 
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Brand NameUNKNOWN PARIETEX PROGRIP
Type of DeviceMESH, SURGICAL, POLYMERIC
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 Key12591809
MDR Text Key275223669
Report Number9615742-2021-02264
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeSZ
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 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN PARIETEX PROGRIP
Device Catalogue NumberUNKNOWN PARIETEX PROGRIP
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 Received09/22/2021
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: 10/07/2021 Patient Sequence Number: 1
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