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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS UNKNOWN SYMBOTEX MESH MESH, SURGICAL, POLYMERIC

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SOFRADIM PRODUCTION SAS UNKNOWN SYMBOTEX MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Model Number UNKNOWN SYMBOTEX MESH
Device Problems Degraded (1153); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Patient Problems Adhesion(s) (1695); Emotional Changes (1831); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Scar Tissue (2060); Hernia (2240); Ascites (2596); Fluid Discharge (2686); Fibrosis (3167); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
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 laparoscopic therapeutic treatment of a ventral hernia. It was reported that after the implant, the patient experienced chronic pain, edema, loculated fluid, inflammation, infection, fluid collection, erythematous skin changes, adhesions, recurrence, and fibrous tissue. Post-operative patient treatment included revision surgery, antibiotics, lysis of adhesions, abdominal wall reconstruction, vac placement, hernia repair with new mesh, drain placement, removal of mesh, and admission to hospital. Relevant tests/laboratory data: (b)(6) 2017: abdominal ct scan showed extensive mesenteric edema as well as what appears to be loculated fluid along the underside of a hernia mesh. Findings suggestive of an inflammatory process related to hernia mesh, possibly infectious. On (b)(6) 2017: abdominal ct scan showed interval slight decrease in size of elongated fluid collection with indistinct posterior to anterior abdominal hernia mesh, interval decrease in associated mesenteric fat stranding. Unrelated findings of trace bilateral pleural effusions and perihepatic ascites 14 sep 2017: pathology report from abdominal mesh explant showed associated benign fibrous tissue with chronic inflammation.
 
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Brand NameUNKNOWN SYMBOTEX MESH
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 Key12178632
MDR Text Key261933832
Report Number9615742-2021-01750
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 02/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN SYMBOTEX MESH
Device Catalogue NumberUNKNOWN SYMBOTEX MESH
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2022
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: 07/15/2021 Patient Sequence Number: 1
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