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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 SYM1510
Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Bacterial Infection (1735); Cellulitis (1768); Purulent Discharge (1812); Erythema (1840); Foreign Body Reaction (1868); Granuloma (1876); Failure of Implant (1924); Unspecified Infection (1930); Inflammation (1932); Nausea (1970); Pain (1994); Hernia (2240); Ulcer (2274); Impaired Healing (2378); Respiratory Failure (2484); Fluid Discharge (2686); Fibrosis (3167); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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 a ventral incisional hernia. It was reported that after the implant, the patient experienced mesh deformation, abscess, adhesions, infection, recurrence, mesh migration, cellulitis, bacterial infection, granuloma, ulcer, granulation tissue, inflammation, fibrosis, foreign body reaction, mrsa, pain, nausea, nonhealing wound, abdominal pain, purulent material, erythema, skin warmth, failure of mesh, fibrinous reactive tissue, respiratory failure, draining wound, disrupted mesh, and meshoma/balling. Post-operative patient treatment included revision surgery, hernia repair with new mesh, admission to hospital, antibiotics, lysis of adhesions, removal of hernia sac, reduction of hernia contents, debridement of skin/subcutaneous tissue/muscle/muscle fascia, abdominal wall component separation, placement of drains, closure of rectus fascia, debridement/resection of skin/subcutaneous stitch granuloma, fibrinous reactive tissue dissected, medication, and removal of 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
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key11422173
MDR Text Key234947879
Report Number9615742-2021-00471
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 03/05/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/05/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSYM1510
Device Catalogue NumberSYM1510
Device LOT NumberPQK1072X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/07/2016
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: 03/05/2021 Patient Sequence Number: 1
Treatment
SYM2520 STEX 25X20CM X1 (LOT#PSF0900X)
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