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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS PELVICOL MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number 482412
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Prolapse (2475)
Event Date 07/31/2003
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 of cystocele. It was reported that after the implant, the patient experienced recurrence. Post-operative patient treatment included revision surgery, abdominal sacrocolpopexy, abdominal paravaginal repair, cystourethroscopy, and recurrence repair with new mesh.

 
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Brand NamePELVICOL
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 Key10083044
MDR Text Key191833819
Report Number9615742-2020-01167
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 05/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/22/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/19/2005
Device MODEL Number482412
Device Catalogue Number482412
Device LOT Number03802B
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2020
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: 05/22/2020 Patient Sequence Number: 1
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