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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH BALLYMONEY - IVS TUNNELLER MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS MESH BALLYMONEY - IVS TUNNELLER MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number IVS02
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Erosion (1750); Hemorrhage/Bleeding (1888); Perforation (2001); Abnormal Vaginal Discharge (2123); Unspecified Tissue Injury (4559)
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. It was reported that after the implant, the patient experienced vaginal discharge/leucorrhea, bleeding protrusion, and vaginal erosion. Post-operative patient treatment included postureitropexia uretrolysis and removal of strip.

 
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Brand NameMESH BALLYMONEY - IVS TUNNELLER
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 Key11138912
MDR Text Key225730885
Report Number9615742-2021-00119
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 01/08/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/08/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2005
Device MODEL NumberIVS02
Device Catalogue NumberIVS02
Device LOT Number0206004-10
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
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: 01/08/2021 Patient Sequence Number: 1
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