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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Post Operative Wound Infection (2446); No Code Available (3191)
Event Date 12/25/2009
Event Type  Injury  
Manufacturer Narrative

(b)(4). Title long-term results of laparoscopic treatment of spigelian hernias with mesh source asian j endosc surg, volume 3, 2010 (71-76) article number: 7 date of publication: 25 december 2009. If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to literature source of study performed from february 1991 through april 2008, spigelian hernias treated laparoscopically with mesh were prospectively followed. From the 18 subjects, three complications were observed with two patients suffering from atelectasis and the third suffering from wound infection. These complications were resolved with conservative management and did not require further intervention.

 
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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 Key8733252
MDR Text Key149159423
Report Number9615742-2019-02297
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 06/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberUNKNOWN PARIETEX
Device Catalogue NumberUNKNOWN PARIETEX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
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: 06/26/2019 Patient Sequence Number: 1
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