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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML; BIOLOGICS
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SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML; BIOLOGICS Back to Search Results
Model Number 00-1111-001-00
Health Effect - Clinical Codes Pain (1994); Dizziness (2194); Ambulation or Postural Difficulties (2544); Unspecified Respiratory Problem (4464)
Date of Event 06/08/2022
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the patient had extreme pain, dizziness, upper respiratory issues and was unable to walk four days after having the injection.Her entire body started to vibrate.No additional patient consequences were being reported.
 
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Brand Name
GEL-ONE X-LINKED HYALUR 3ML
Common Device Name
BIOLOGICS
Manufacturer (Section D)
SEIKAGAKU CORPORATION
6-1, marunouchi
1-chrome chiyoda-ku, tokyo 100-0 005
JA  100-0005
MDR Report Key15157026
Report Number0001822565-2022-02231
Device Sequence Number5323373
Product Code MOZ
UDI-Device Identifier04987541300911
UDI-Public(01)04987541300911
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/27/2022
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? No
Operator of Device Health Professional
Device Model Number00-1111-001-00
Device Catalogue Number00111100100
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/22/2022
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/03/2022
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient SexFemale
Patient Weight66 KG
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