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

Catalog Number 00111100100

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was reported by the patient that the gel one injection did not work well for him. There has been no improvement even after 9 days of the injection. No additional patient consequences are known.

• Brand Name: GEL-ONE X-LINKED HYALUR 3ML
• Type of Device: BIOLOGICS
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo 100-0 005; JA 100-0005
• MDR Report Key: 11155426
• MDR Text Key: 226283458
• Report Number: 0001822565-2021-00139
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 00111100100
• Device Lot Number: 0020H26G
• Was Device Available for Evaluation?: No Answer Provided

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/31/2020
• 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: Invalid Data

Patient Treatment Data

Date Received: 01/12/2021 Patient Sequence Number: 1