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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE SYRINGE ACID, HYALURONIC, INTRAARTICULAR

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ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT GEL-ONE SYRINGE ACID, HYALURONIC, INTRAARTICULAR Back to Search Results
Device Problems Material Separation (1562); Failure to Deliver (2338); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Route of administration: intra-articularly to the left knee; spontaneous call from (b)(6)licensed practical nurse from md office calling to report malfunctioning of gel-one syringe, she said when doing the injection the needle came off and got separated and the medication didn't get injected. No adverse event reported. Missed dose reported. Unk if md office has defective device on hand. No further info available. Reported to (b)(4) by health professional.
 
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Brand NameGEL-ONE SYRINGE
Type of DeviceACID, HYALURONIC, INTRAARTICULAR
Manufacturer (Section D)
ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT
MDR Report Key10785600
MDR Text Key214798615
Report NumberMW5097634
Device Sequence Number1
Product Code MOZ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/21/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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