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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 SYM15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Emotional Changes (1831); Pain (1994); Discomfort (2330); Injury (2348); Weight Changes (2607); No Code Available (3191); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative

Concomitant medical product: bard capsure x2 (product id: 0113230, lot number: huzi1854). (b)(4). 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 laparoscopic therapeutic treatment of an umbilical hernia. It was reported that after the implant, the patient experienced pain, sore, irregular bowel movements, constipation, dry heaving, weight gain, and emotional wreck. Post-operative patient treatment included revision surgery.

 
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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 Key10242115
MDR Text Key197848676
Report Number9615742-2020-01442
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK131969
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 07/07/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2021
Device MODEL NumberSYM15
Device Catalogue NumberSYM15
Device LOT NumberPQC0916X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/07/2016
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: 07/07/2020 Patient Sequence Number: 1
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