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

Catalog Number 00111100100

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Urticaria (2278); Swelling/ Edema (4577)

Event Date 09/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 approximately one (1) week ago that the patient received a gel-one injection.Approximately thirty (30) minutes after injection, patient experienced hives, itchiness, and swelling.Subsequently, patient was taken to the er and received an antihistamine.Attempts have been made and no further information has been provided.

• Brand Name: GEL-ONE X-LINKED HYALUR 3ML
• Type of Device: PROSTHESIS, BIOLOGICS
• Manufacturer (Section D): SEIKAGAKU CORPORATION; 6-1, marunouchi; 1-chrome chiyoda-ku, tokyo 100-0 005; JA 100-0005
• MDR Report Key: 12547815
• MDR Text Key: 273813970
• Report Number: 0001822565-2021-02765
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/29/2021

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: Health Professional
• Device Catalogue Number: 00111100100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR