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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

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SEIKAGAKU CORPORATION GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Model Number 00-1111-001-00
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
This case is received by seikagaku corporation on october 26, 2020 from the fda as mw5097048 dated october 16, 2020.According to the result of investigation, there were no deviations or out-of-specifications found in the manufacturing process, the in-process testing, the release testing, and the environmental monitoring for lot# 0020d24g.
 
Event Description
2020-unk - a male patient received gel-one.(b)(6) 2020 - the patient was in hospice.Event ongoing.
 
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Brand Name
GEL-ONE
Type of Device
ACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
SEIKAGAKU CORPORATION
marunouchi center building
6-1, marunouchi 1-chome
chiyoda-ku, tokyo 100-0 005
JA  100-0005
Manufacturer (Section G)
SEIKAGAKU CORPORATION - TAKAHAGI PLANT
258-5, aza-matsukubo
oaza-akahama
takahagi-shi, ibaraki 318-0 001
JA   318-0001
Manufacturer Contact
pharmacovigilance dept
marunouchi center building
6-1, marunouchi 1-chome
chiyoda-ku, tokyo 100-0-005
JA   100-0005
MDR Report Key10892669
MDR Text Key217919764
Report Number9612392-2020-00013
Device Sequence Number1
Product Code MOZ
UDI-Device Identifier04987541300911
UDI-Public(01)04987541300911(17)220802(10)0020D24G
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/26/2020
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? No
Device Operator Health Professional
Device Expiration Date08/02/2022
Device Model Number00-1111-001-00
Device Catalogue Number00-1111-001-00
Device Lot Number0020D24G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/26/2020
Initial Date FDA Received11/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ABIRATERONE ACETATE (250 MG); CYCLOBENZAPRINE; OXYCODONE; PREDNISONE; SENNA
Patient Outcome(s) Other;
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