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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 SYM12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Ischemia (1942); Pain (1994); Hernia (2240); Injury (2348); Abdominal Distention (2601)
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 an incisional hernia. It was reported that after implant, the patient experienced recurrence, bulge, severe pain, adhesions and omentum ischemia. Post-operative patient treatment included revision surgery with removal of old mesh and new ethicon proceed mesh implanted.
 
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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 Key8923745
MDR Text Key155324196
Report Number9615742-2019-02869
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521190344
UDI-Public10884521190344
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
Report Date 08/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2019
Device Model NumberSYM12
Device Catalogue NumberSYM12
Device Lot NumberPOE0521X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/05/2014
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: 08/22/2019 Patient Sequence Number: 1
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