MAUDE Adverse Event Report: SEIKAGAKU CORP., TAKAHAGI PLANT GEL-ONE ACID, HYALURONIC, INTRAARTICULAR

Lot Number 0017Z20G

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Tingling (2171)

Event Date 01/28/2019

Event Type  Injury  

Event Description

Pt reports being hospitalized with tingling and pain through entire body. Zimmer biomet.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP., TAKAHAGI PLANT
• MDR Report Key: 8523219
• MDR Text Key: 142461263
• Report Number: MW5085941
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 06/18/2019
• Device Lot Number: 0017Z20G
• Was Device Available for Evaluation?: No
• 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?

Patient Treatment Data

Date Received: 04/16/2019 Patient Sequence Number: 1