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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML INSTRUMENT, BIOLOGICS

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SEIKAGAKU CORPORATION GEL-ONE X-LINKED HYALUR 3ML INSTRUMENT, BIOLOGICS Back to Search Results
Catalog Number 00111100100
Device Problems Break (1069); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/16/2021
Event Type  malfunction  
Event Description
It was reported approximately three (3) weeks ago that a gel-one injection was received with a broken barrel flange. The finger grip unable to stay attached not allowing for accurate injection. No additional information is available. No adverse event was reported. Attempts have been made and no further information has been provided.
 
Manufacturer Narrative
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. 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.
 
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Brand NameGEL-ONE X-LINKED HYALUR 3ML
Type of DeviceINSTRUMENT, BIOLOGICS
Manufacturer (Section D)
SEIKAGAKU CORPORATION
6-1, marunouchi
1-chrome chiyoda-ku, tokyo 100-0 005
JA 100-0005
MDR Report Key12820235
MDR Text Key282490734
Report Number0001822565-2021-03295
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 Administrator/Supervisor
Type of Report Initial
Report Date 11/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number00111100100
Device Lot Number0020Z02G
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

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