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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 SYM2015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Unspecified Infection (1930); Nausea (1970); Pain (1994); Rash (2033); Staphylococcus Aureus (2058); Scar Tissue (2060); Seroma (2069); Tachycardia (2095); Vomiting (2144); Chills (2191); Hernia (2240); Discomfort (2330); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); No Code Available (3191)
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 a ventral hernia. It was reported that after implant, the patient experienced recurrence, retraction of rectus abdominis muscles, adhesions, scar tissue, firm nodule, abdominal pain, rash, infection, seroma, purulent material, redness, tenderness, fever, chills, nausea, tachycardia, emesis, distention, small bowel obstruction, fluid collections, staphylococcus aureus, corynebacterium, and pain. Post-operative patient treatment included revision surgery, bilateral component separation, pain medication, hernia repair with new mesh, admission to hospital, bilateral transversus abdominis plane block, abdominal drain, antibiotics, removal of drain, multiple fluid boluses, transfer to critical care unit, 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 Key10639544
MDR Text Key210176469
Report Number9615742-2020-02292
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 10/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2019
Device MODEL NumberSYM2015
Device Catalogue NumberSYM2015
Device LOT NumberPOL0671X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/07/2015
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: 10/06/2020 Patient Sequence Number: 1
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