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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 SYM2520OS
Device Problems Material Erosion (1214); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Corneal Pannus (1447); Abdominal Pain (1685); Abscess (1690); Adhesion(s) (1695); Erosion (1750); Emotional Changes (1831); Inflammation (1932); Ischemia (1942); Laceration(s) (1946); Nausea (1970); Pain (1994); Scarring (2061); Seroma (2069); Vomiting (2144); Discharge (2225); Excessive Tear Production (2235); Hernia (2240); Discomfort (2330); Injury (2348); Depression (2361); Impaired Healing (2378); Obstruction/Occlusion (2422); Ascites (2596); Abdominal Distention (2601); Fibrosis (3167); No Code Available (3191)
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 symptomatic ventral incisional hernia. It was reported that after implant, the patient experienced seroma drainage, pain, recurrence, adhesions, residual pocket seroma, mesh erosion into both sides of abdominal cavity, recurrent small bowel obstruction, serosal tears, chronic abdominal pain, chronic depression, and small bowel lesions. Post-operative patient treatment included excision of mesh due to pain, repair of resultant ventral incisional hernia with new mesh, lysis of multiple dense adhesions, exploratory laparotomy with extensive lysis of adhesions, injection due to chronic abdominal pain, large complex incarcerated incisional hernia recurrence requiring placement of new mesh, small bowel lesions repaired, cholecystectomy as well as excision of mesh fragments.
 
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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 Key8765386
MDR Text Key150175738
Report Number9615742-2019-02433
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521190504
UDI-Public10884521190504
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131969
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
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2019
Device Model NumberSYM2520OS
Device Catalogue NumberSYM2520OS
Device Lot NumberPOD0596X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/13/2014
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: 07/05/2019 Patient Sequence Number: 1
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