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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 Pain (1994); Hernia (2240); Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 06/22/2019
Event Type  Injury  
Manufacturer Narrative

Title of article: laparoscopic totally extra-peritoneal groin hernia repair with self-gripping polyester mesh: a series of 780 repairs authors: bethany stavert, daniel l. Chan, john ozmen, and ken loi year: 2019. (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the literature, the study conducted includes a retrospective case series. The study included 514 patients who underwent 780 laparoscopic inguinal hernia repairs. Post-operatively, it was reported that 4 hernia recurrences occurred and three of these subsequently underwent open redo-hernia repairs. Thirteen patients reported chronic pain and 1 patient experienced would infection.

 
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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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key9203438
MDR Text Key162872672
Report Number9615742-2019-03475
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeAS
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 10/17/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/17/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received09/30/2019
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: 10/17/2019 Patient Sequence Number: 1
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