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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
Catalog Number 00111100100
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2020
Event Type  Injury  
Event Description
It was reported that when the physician went to inject into the patient's knee, the needle snapped off. No patient consequences were reported as a result of this event.
 
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Brand NameGEL-ONE X-LINKED HYALUR 3ML
Type of DeviceBIOLOGICS
Manufacturer (Section D)
SEIKAGAKU CORPORATION
6-1, marunouchi
1-chrome chiyoda-ku, tokyo 100-0 005
JA 100-0005
MDR Report Key9877834
MDR Text Key185969471
Report Number0001822565-2020-00900
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00111100100
Device Lot Number0019X22G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/04/2020
Event Location Hospital
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/25/2020 Patient Sequence Number: 1
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