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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 Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Abscess (1690); Adhesion(s) (1695); Purulent Discharge (1812); Hematoma (1884); Unspecified Infection (1930); Inflammation (1932); Internal Organ Perforation (1987); Seroma (2069); Injury (2348); Obstruction/Occlusion (2422); Ascites (2596); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 laparoscopic ventral incisional hernia. It was reported that after the implant, the patient experienced small bowel obstruction, small bowel perforation, infection, hematoma, fluid collection and air anterior to mesh implant, intraabdominal abscess, adhesions, seroma, mass, inflammation and pus pockets. Post-operative patient treatment included revision surgery, exploratory laparoscopy with lysis, repair of small bowel perforation, small bowel resection, excision of mesh, drainage of intraabdominal abscess, drainage of right rectus sheath hematoma, removal and bypass of a portion of small bowel with enteroenterostomy, primary anastomosis and appendectomy.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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. Product was used for therapeutic treatment. The patient underwent a laparoscopic ventral incisional hernia repair with mesh. He had revision surgery 9 days post-operative. The patient experienced surgical revision.
 
Manufacturer Narrative
This information was received as a part of an extensive mesh litigation submission to medtronic. The fda was notified of this large complaint receipt. Due to the volume of complaint information received by medtronic, this resulted in a report beyond the 30 day target. 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 laparoscopic ventral incisional hernia. It was reported that after the implant, the patient experienced small bowel obstruction, small bowel perforation, and infection. Post-operative patient treatment included revision surgery, small bowel resection, and excision of mesh.
 
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 resulting in an unspecified adverse outcome. Product was used for therapeutic treatment. The patient underwent a laparoscopic ventral incisional hernia repair with mesh. He had revision surgery 9 days post-operative. The patient experienced surgical revision.
 
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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
MDR Report Key7174607
MDR Text Key275052593
Report Number9615742-2018-00066
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521190481
UDI-Public10884521190481
Combination Product (y/n)N
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup,Followup
Report Date 01/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Model NumberSYM2520
Device Catalogue NumberSYM2520
Device Lot NumberPOJ0903X
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/09/2018 Patient Sequence Number: 1
Treatment
UNK PROTACK(LOT#: UNKNOWN)
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