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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 Pain (1994); Tissue Damage (2104); Hernia (2240); Injury (2348); Disability (2371); No Code Available (3191)
Event Date 05/31/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, post operatively, on an umbilical hernia procedure, just after the implantation occurred, there was significant abdominal pain and biological disorders followed by a recurrence of umbilical and migratory prosthetic hernia that has led to other abdominal hernias and lifelong disability. Medical or surgical intervention was needed to prevent a permanent impairment of a function. There was tissue damage. They explanted the device to complete the case.
 
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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 Key8636986
MDR Text Key145958988
Report Number9615742-2019-01732
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model NumberSYM12
Device Catalogue NumberSYM12
Device Lot NumberPPE0070X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/20/2015
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: 05/23/2019 Patient Sequence Number: 1
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