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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 Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2019
Event Type  malfunction  
Event Description
It was reported that the sterile package was damaged which caused damage to the plunger. Attempts have been made and no further information has been provided.
 
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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 Key9532378
MDR Text Key187249095
Report Number0001822565-2019-05437
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 12/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00111100100
Device Lot Number0019H05G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date12/23/2019
Event Location No Information
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
Removal/Correction NumberN/A

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