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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS UNKNOWN PARIETEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN PARIETEX PRODUCT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Seroma (2069); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Title: self-fixing parietex progrip versus the standard sutured prolene mesh in tension-free repair of inguinal hernia: effect on testicular volume and testicular blood flow source: department of surgery, faculty of medicine, university of alexandria, el sultan hussein street, el-azarita, khartoum square, alexandria 21131, egypt date published: 13 june 2018. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, after the inguinal hernia repair surgery, patients experienced post-operative complications such as seroma, hematoma, wound infection, epididimo orchitis, and hospital re-admission.

 
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Brand NameUNKNOWN PARIETEX
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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key8191774
MDR Text Key131226420
Report Number9615742-2018-02895
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeEG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2018
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
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2018
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: 12/21/2018 Patient Sequence Number: 1
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