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U.S. Department of Health and Human Services

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

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SOFRADIM PRODUCTION SAS SYMBOTEX MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number SYM9
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Calcium Deposits/Calcification (1758); Foreign Body Reaction (1868); Necrosis (1971); Pain (1994); Hernia (2240); Discomfort (2330); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 laparoscopic therapeutic treatment of a ventral incisional hernia. It was reported that after the implant, the patient experienced recurrence, fibroadipose tissue, foreign material, calcification, giant cell reaction, fat necrosis, pain, discomfort, lesions, and adhesions. Post-operative patient treatment included removal of mesh, lysis of adhesions, excisional biopsy of the small peritoneal lesions, injection for pain control, and hernia repair with new mesh.

 
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Brand NameSYMBOTEX
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 Key11116444
MDR Text Key225051530
Report Number9615742-2021-00007
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 01/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/05/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSYM9
Device Catalogue NumberSYM9
Device LOT NumberPRC0043X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/11/2017
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: 01/05/2021 Patient Sequence Number: 1
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