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

Lot Number 0020G20G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033)

Event Date 10/20/2020

Event Type  Injury  

Event Description

Patient received gel-one injection into her left knee on (b)(6) 2020.She reports that approximately 3-4 days later she developed itchy skin, and then developed hives and a red, bumpy rash all over her body (except her face).She has been on numerous rounds of steroids, antihistamines, creams, etc.And has not had any relief of symptoms.She has stopped other medications that she had been on and her other physicians have ruled out any medication reactions.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER BIOMET / SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 10976320
• MDR Text Key: 220762597
• Report Number: MW5098277
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541-0300-91
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/08/2022
• Device Lot Number: 0020G20G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 68