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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 SYM3020
Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001); Material Split, Cut or Torn (4008)
Patient Problems Abscess (1690); Adhesion(s) (1695); Erosion (1750); Seroma (2069); Hernia (2240); Ascites (2596); Fluid Discharge (2686); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Concomitant product: bard- mesh ventralex st sm circle, product id 595007, lot # hudr1683, unknown tacker (lot# unknown). 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 a laparoscopic therapeutic treatment of a incisional hernia and open epigastric incisional hernia. The patient¿s attorney alleged a deficiency against the device. It was reported that after implant, the patient experienced adhesions, mesh pulled away, omentum and bowel were protruding through prior mesh, drainage of seroma through abdominal wall, prior mesh appeared to be distorted/palpated, abscess, mesh erosion, fluid filled abdominal wall, peritoneal fluid, and recurrence. Post-operative patient treatment included lysis of adhesions, removal of mesh, hernia repair surgery with mesh, catheter placement, drainage surgery, bilateral transversus abdominis release, seroma drained, seroma fluid aspirated, and myofascial component separation.
 
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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
tracy landers
5920 longbow drive
boulder, CO 80301
3035816943
MDR Report Key12029163
MDR Text Key257264914
Report Number9615742-2021-01538
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142908
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYM3020
Device Catalogue NumberSYM3020
Device Lot NumberPRJ0850X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/23/2017
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: 06/18/2021 Patient Sequence Number: 1
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