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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PROSUP

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SOFRADIM PRODUCTION SAS PROSUP Back to Search Results
Model Number PACGK06
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Prolapse (2475); No Code Available (3191)
Event Date 02/19/2019
Event Type  Injury  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, patient had a genitourinary prolapse and after an intervention of promonto double laparoscopic fixation, rectopexy and posterior hysteropexy of a urologist to place the mesh device, patient regularly suffers from cystitis and severe pain during sexual intercourse.

 
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Brand NamePROSUP
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 Key8418423
MDR Text Key138756143
Report Number9615742-2019-00449
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,FOREIGN
Reporter Occupation
Type of Report Initial
Report Date 03/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2018
Device MODEL NumberPACGK06
Device Catalogue NumberPACGK06
Device LOT NumberPNL0996X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/11/2014
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: 03/13/2019 Patient Sequence Number: 1
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