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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS PARIETENE MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS PARIETENE MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number PP1510X3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Foreign Body Reaction (1868); Incontinence (1928); Inflammation (1932); Muscle Weakness (1967); Pain (1994); Scar Tissue (2060); Urinary Retention (2119); Urinary Tract Infection (2120); Burning Sensation (2146); Urinary Frequency (2275); Injury (2348); Obstruction/Occlusion (2422); Prolapse (2475); Hematuria (2558); Dysuria (2684); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment vaginal vault prolapse. It was reported that after the implant, the patient experienced an unspecified adverse outcome.

 
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Brand NamePARIETENE
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 Key10259581
MDR Text Key198388605
Report Number9615742-2020-01566
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberNONE
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/08/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/10/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date01/31/2018
Device MODEL NumberPP1510X3
Device Catalogue NumberPP1510X3
Device LOT NumberSNB0083
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/27/2013
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: 07/10/2020 Patient Sequence Number: 1
Treatment
174006 PROTACK 5MM DISP IN (LOT# UNKNOWN)
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