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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 SYM4232
Device Problems Migration or Expulsion of Device (1395); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abdominal Pain (1685); Abscess (1690); Emotional Changes (1831); Fever (1858); Unspecified Infection (1930); Pain (1994); Scar Tissue (2060); Seroma (2069); Distress (2329); Deformity/ Disfigurement (2360); Unspecified Tissue Injury (4559)
Event Type  Injury  
Event Description
The patient¿s attorney alleged a deficiency against the device. The product was used for therapeutic treatment of a hernia. It was reported that after the implant, the patient experienced seroma, abscess, infection, recurrent fever, abdominal pain, failed mesh, mental anguish, scarring, disfigurement, defective mesh, pain, disability, impairment, loss of enjoyment of life, loose mesh, infection, unincorporated mesh, and emotional distress. Post-operative patient treatment included revision surgery and partial explant of mesh.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key12981859
MDR Text Key282096523
Report Number9615742-2021-02479
Device Sequence Number1
Product Code FTL
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
Type of Report Initial
Report Date 12/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2021
Device Model NumberSYM4232
Device Catalogue NumberSYM4232
Device Lot NumberPQL0492X
Was Device Available for Evaluation? No
Date Manufacturer Received11/23/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/27/2016
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: 12/12/2021 Patient Sequence Number: 1
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