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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 SYM2520
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Hematoma (1884); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Pain (1994); Hernia (2240); Impaired Healing (2378); Thrombosis/Thrombus (4440); 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 laparoscopic therapeutic treatment of an incisional flank hernia. It was reported that after implant, the patient experienced recurrence, adhesions, hematoma, myocardial infarction, intraabdominal bleeding, chronic pain, diastasis recti, blood clot, hypotensive, and suffering. Post-operative patient treatment included revision surgery, abdominal wall reconstruction by release of left posterior rectus sheath and transversus abdominis muscle, hernia repair with new mesh, icu, fluids, medication, drug eluting stent placed, evacuation of hematoma, removal of wound-vac assisted closure, removal of mesh, prevena dressing, and admission to hospital.

 
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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 Key10950694
MDR Text Key219862172
Report Number9615742-2020-02759
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,Followup
Report Date 02/01/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/05/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/31/2016
Device MODEL NumberSYM2520
Device Catalogue NumberSYM2520
Device LOT NumberPNL0643X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/04/2014
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: 12/05/2020 Patient Sequence Number: 1
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