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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 SYM2012E
Device Problems Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Diarrhea (1811); Emotional Changes (1831); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Seroma (2069); Chills (2191); Impaired Healing (2378); Weight Changes (2607); Fluid Discharge (2686); Unspecified Tissue Injury (4559); Decreased Appetite (4569)
Event Type  Injury  
Manufacturer Narrative
Concomitant device: allergan graft matrix tissue strattice biologic mesh 20x25cm (abdomen) (product id: 2025002p, lot number: sp200019-077) 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 the underlay implant, the patient experienced hematoma, abscess, infection, wound-healing issues, nausea, chills, inflammation, loss of appetite, chronic pain, extreme weight loss, diarrhea, seroma, abdominal pain, drainage, and suffering. Post-operative patient treatment included revision surgery, admission to hospital, evacuation of hematoma, negative pressure wound therapy, wound vac, hospitalization, incision/drainage of abscess, antibiotics, ir drain placed, and need for future medical treatment.
 
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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 Key12025063
MDR Text Key257506718
Report Number9615742-2021-01461
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYM2012E
Device Catalogue NumberSYM2012E
Device Lot NumberPRK0440X
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/11/2017
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: 06/18/2021 Patient Sequence Number: 1
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