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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 SYM8OS
Device Problem Material Erosion (1214)
Patient Problems Tissue Damage (2104); No Code Available (3191)
Event Date 03/26/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). Evaluation summary: one device was returned for investigation. A review of the device history record has been performed and no failure that may relate to the reported conditions have been noted. Especially the records related to the collagen casting and the collagen based film results and the mechanical testing of the textile batch were found within specifications. The visual examination of the 2 provided picture shows that during an open procedure. The textile knitting pattern seems to match with symbotex textile knitting pattern. However, the green flap is not visible, and the picture does not allow to detect if a collagen film was present and its state. Neither mesh failure nor adhesions to the mesh are visible. A piece of flat is visible on the mesh. However, we could not determine with the picture if this flat was protruding through the mesh. No fixation system is visible in the picture. Without the sample a detailed investigation could not be performed. The reported condition could not be confirmed. The reported information is too limited to determine the root cause or most probable cause of the reported incident and/or to determine if the incident is associated with a manufacturing or component discrepancy. It should be noted that the incident arrived ¿when they were getting to sew the patient up¿. Based on our investigation and a complaint history review, the manufacture of the device is not suspected. There is no indication that there is a defective lot or that this event represents an emerging adverse quality trend. Although a specific root cause analysis could not be performed, the incident is maintained in our database for a broader trend analysis. If additional information is obtained, or the sample is returned, we will re-open this investigation if information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during a ventral hernia procedure, the surgeon noted that the mesh was defective due to the fat was protruding through the mesh when it was sewn into the abdominal wall. Removed the reported mesh and replaced with a new a device. It was sutured and the skin was stapled back together. The surgical time was extended 45 minutes due to the product problem.
 
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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 Key8523296
MDR Text Key142230250
Report Number9615742-2019-01363
Device Sequence Number1
Product Code FTL
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSYM8OS
Device Catalogue NumberSYM8OS
Device Lot NumberPRK1515X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2018
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: 04/17/2019 Patient Sequence Number: 1
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