MAUDE Adverse Event Report: SEIKAGAKU CORPORATION GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

Model Number 00-1111-001-00

Device Problems No Display/Image (1183); Device Fell (4014)

Patient Problem Loss of consciousness (2418)

Event Date 06/17/2018

Event Type  Injury  

Manufacturer Narrative

This is a definitive report.This case is received by seikagaku corporation on (b)(6) 2018 from the fda mw5078007 dated (b)(6) 2018.Seikagaku corporation is also submitting this report on behalf of zimmer, inc.As the importer with authorization by the exemption number (b)(4).

Event Description

On (b)(6) 2018 - a female patient who received gel-one injection in the left knee on unknown date fell and blacked out.On (b)(6) 2018 - the patient went to er and was treated.Event outcome was reported as "hospitalization" by the reporter, "other health professional".On (b)(6) 2018 - the event was resolved.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0 005; JA 100-0005
• Manufacturer (Section G): SEIKAGAKU CORPORATION-TAKAHAGI PLANT; 258-5,aza-matsukubo; oaza-akahama; takahagi-shi, ibaraki 318-0 001; JA 318-0001
• Manufacturer Contact: pharmacovigilance dept. ; marunouchi center building; 6-1, marunouchi 1-chome; chiyoda-ku, tokyo 100-0-005 ; JA 100-0005
• MDR Report Key: 7726479
• MDR Text Key: 115352092
• Report Number: 9612392-2018-00011
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• PMA/PMN Number: P080020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/02/2018

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 Model Number: 00-1111-001-00
• Device Catalogue Number: 00-1111-001-00
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/05/2018
• Event Location: Home
• Initial Date Manufacturer Received: 07/02/2018
• Initial Date FDA Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization