GEL-ONE X-LINKED HYALUR 3ML 00111100100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-19 for GEL-ONE X-LINKED HYALUR 3ML 00111100100 manufactured by Seikagaku Corporation.

MAUDE Entry Details

Report Number0001822565-2020-01023
MDR Report Key9857146
Date Received2020-03-19
Date of Report2020-03-19
Date of Event2019-09-12
Date Facility Aware2020-03-18
Date Added to Maude2020-03-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGEL-ONE X-LINKED HYALUR 3ML
Generic NameBIOLOGICS
Product CodeMOZ
Date Received2020-03-19
Catalog Number00111100100
Lot Number0019F07G
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSEIKAGAKU CORPORATION
Manufacturer Address6-1, MARUNOUCHI 1-CHROME CHIYODA-KU, TOKYO 100-0005 JA 100-0005


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-19

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