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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETEX

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SOFRADIM PRODUCTION SAS PARIETEX Back to Search Results
Model Number PAT2020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Prolapse (2475); No Code Available (3191)
Event Date 09/01/2009
Event Type  Injury  
Manufacturer Narrative

(b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, post-operatively, the patient experienced myofascial and perineal syndrome with pudendal algae. Permanent and disabling pain for 10 years. Sitting position impossible. Difficulties in private and professional life. Cure of prolapse by the low route and installation of a prolapse plate was needed to prevent a permanent impairment.

 
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Brand NamePARIETEX
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 Key8450093
MDR Text Key139798095
Report Number9615742-2019-00651
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 COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 03/25/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberPAT2020
Device Catalogue NumberPAT2020
Device LOT NumberPIF00046
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2019
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: 03/25/2019 Patient Sequence Number: 1
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