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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 SYM12
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); Material Split, Cut or Torn (4008)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Diarrhea (1811); Purulent Discharge (1812); Edema (1820); Emotional Changes (1831); Fistula (1862); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Scar Tissue (2060); Scarring (2061); Ulceration (2116); Discharge (2225); Hernia (2240); Distress (2329); Injury (2348); Bowel Perforation (2668); Fluid Discharge (2686); No Code Available (3191); Stomach Ulceration (4488); Unspecified Tissue Injury (4559); Swelling/ Edema (4577); 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 an incisional hernia. It was reported that after the implant, the patient experienced torn mesh, infected mesh, bowel perforation, fecal contamination, bowel injury, acute serositis, adhesions, scarring, unsecured mesh, recurrence, nausea, diarrhea, inflammation, focal ulceration, fistula, abdominal pain, edema, sinus tract, induration, purulent material, discharge, scar tissue, and pain/ suffering. Post-operative patient treatment included revision surgery, hernia repair with new mesh, removal of mesh, wound vac, enterotomy resected, and bowel resection with primary stapled anastamosis.
 
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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 Key10261065
MDR Text Key198434094
Report Number9615742-2020-01588
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521190344
UDI-Public10884521190344
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 03/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2016
Device Model NumberSYM12
Device Catalogue NumberSYM12
Device Lot NumberPNJ0488X
Was Device Available for Evaluation? No
Date Manufacturer Received02/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/31/2013
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: 07/10/2020 Patient Sequence Number: 1
Treatment
UNKNOWN TACKER
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