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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 SYM2015
Device Problems Material Perforation (2205); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Discharge (2225); Excessive Tear Production (2235); Discomfort (2330); Injury (2348); Impaired Healing (2378); Bowel Perforation (2668); Fluid Discharge (2686); No Code Available (3191); Unspecified Tissue Injury (4559)
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 therapeutic treatment of an abdominal hernia. It was reported that after implant, the patient experienced serosal tears, phlegmon, inflammation, fistula, bowel perforation, adhesions to small intestine, adhesions, infection, open draining wound and abscess. Post-operative patient treatment included surgery to remove 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
tracy landers
5920 longbow drive
boulder,co, CT 80301
3035816943
MDR Report Key8760588
MDR Text Key150017486
Report Number9615742-2019-02374
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521190450
UDI-Public10884521190450
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Remedial Action Replace
Type of Report Initial,Followup
Report Date 03/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2016
Device Model NumberSYM2015
Device Catalogue NumberSYM2015
Device Lot NumberPNJ0238X
Was Device Available for Evaluation? No
Date Manufacturer Received02/23/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/07/2013
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: 07/03/2019 Patient Sequence Number: 1
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