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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 SYM15
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Pain (1994); Scar Tissue (2060); Hernia (2240); Discomfort (2330); 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 of epigastric ventral hernia. It was reported that after the implant, the patient experienced pain, mental pain, suffering, discomfort, recurrence, adhesions, mesh migration, device defective, scarring, permanent impairment and loss of enjoyment of life. Post-operative patient treatment included lysis of adhesions, reduction of the omentum, placement of wound vac, excision of hernia sac and mesh both were sent to pathology and hernia repair with bard 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 80301
3035816943
MDR Report Key14283297
MDR Text Key290794012
Report Number9615742-2022-00426
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521190368
UDI-Public10884521190368
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
Type of Report Initial
Report Date 05/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYM15
Device Catalogue NumberSYM15
Was Device Available for Evaluation? No
Date Manufacturer Received04/13/2022
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: 05/04/2022 Patient Sequence Number: 1
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