• 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 X-LINKED HYALUR 3ML PROSTHESIS, BIOLOGICS

  • 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 X-LINKED HYALUR 3ML PROSTHESIS, BIOLOGICS Back to Search Results
Catalog Number 00111100100
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Inadequate Pain Relief (2388)
Event Date 05/25/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Product device code - moz. Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it remains implanted. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
 
Event Description
It was reported that a patient underwent a gel-one injection approximately seven (7) weeks ago. Subsequently, patient has not experienced relief since the procedure, and reported an increase of pain approximately five (5) weeks post-injection. Attempts have been made and no further information has been provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameGEL-ONE X-LINKED HYALUR 3ML
Type of DevicePROSTHESIS, BIOLOGICS
Manufacturer (Section D)
SEIKAGAKU CORPORATION
6-1, marunouchi
1-chrome chiyoda-ku, tokyo
MDR Report Key12159692
MDR Text Key261433129
Report Number0001822565-2021-01923
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
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Date07/01/2021
Event Location No Information
Date Manufacturer Received07/13/2021
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: 07/13/2021 Patient Sequence Number: 1
-
-