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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 SYM2015
Device Problem Material Split, Cut or Torn (4008)
Patient Problems Pain (1994); Hernia (2240); Obstruction/Occlusion (2422)
Event Date 03/09/2022
Event Type  Injury  
Event Description
According to the reporter, 5 years post-operative of a spigelian hernia intraperitoneal onlay mesh (ipom) repair procedure, the patient had to have an additional robotic transabdominal preperitoneal (rtapp) hernia surgery due to a recurrence.The patient had bowel obstruction and chronic pain.During recurrent operation, a hole in the middle of the mesh was detected.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, five years post-operative of a spigelian hernia intraperitoneal onlay mesh (ipom) repair procedure, the patient had to have an additional robotic transabdominal preperitoneal (rtapp) hernia surgery due to a recurrence.It was noted the size of the defect back in 2017 was 9x5 centimeter.The patient had bowel obstruction and chronic pain.During recurrent operation, a hole in the middle of the mesh was detected.
 
Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SYMBOTEX
Type of Device
MESH, 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 Key13891730
MDR Text Key287838781
Report Number9615742-2022-00253
Device Sequence Number1
Product Code FTL
UDI-Device Identifier10884521190450
UDI-Public10884521190450
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 Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2021
Device Model NumberSYM2015
Device Catalogue NumberSYM2015
Device Lot NumberPQG1389X
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/09/2022
Initial Date FDA Received03/24/2022
Supplement Dates Manufacturer Received03/21/2022
Supplement Dates FDA Received04/05/2022
Date Device Manufactured08/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age64 YR
Patient SexFemale
Patient Weight79 KG
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