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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 Adhesion(s) (1695); Seroma (2069); Post Operative Wound Infection (2446)
Event Date 04/01/2018
Event Type  Injury  
Manufacturer Narrative

Title: polylactide-caprolactone composite mesh for ventral hernia repair: a prospective, randomized, single-blind controlled trial source: department of hernia and abdominal wall surgery, beijing chao-yang hospital, capital medical university, beijing, china, date of publication: 2018. If information is provided in the future, a supplemental report will be issued. (b)(4).

 
Event Description

According to literature source of study performed, controlled trial was designed to compare results in patients undergoing laparoscopic ventral hernia repair. 80 patients who needed repair surgery for primary or secondary ventral hernias were enrolled in this study. The results revealed that two patients developed mesh-viscera adhesions after surgery, 21 patients developed post-surgical seromas in the surgery area and one patient developed postoperative wound infection. Polylactide-caprolactone composite mesh for ventral hernia repair: a prospective, randomized, single-blind controlled trial ying-mo shen, 2018.

 
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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 Key8229497
MDR Text Key132481933
Report Number9615742-2019-00025
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 01/08/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2019
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 Received05/10/2018
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: 01/08/2019 Patient Sequence Number: 1
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