• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Date 04/02/2021
Event Type  Death  
Manufacturer Narrative
No detailed information is available through our us partner because no contact information is provided. This case is received by seikagaku corporation on july 13, 2021 from the fda as mw5102308 dated july 8, 2021.
 
Event Description
Patient's husband reported that the patient passed away on (b)(6) 2021.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGEL-ONE
Type of DeviceACID, 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 Key12281502
MDR Text Key265207199
Report Number9612392-2021-00003
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
PMA/PMN Number
P080020
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial
Report Date 07/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number00-1111-001-00
Device Catalogue Number00-1111-001-00
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/05/2021 Patient Sequence Number: 1
-
-