MAUDE Adverse Event Report: ZIMMER/SEIKAGAKU CORP. GEL-ONE; ACID, HYALURONIC, INTRAARTICULAR

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

Patient Problems Abrasion (1689); Fall (1848); Loss of consciousness (2418)

Event Date 06/17/2018

Event Type  Injury  

Event Description

Patient reported that she fell yesterday and blacked out.She scraped her right knee (she injects in left) and went to er and was treated.Event is resolved on (b)(6) 2018.(b)(4)has not sent the medication yet.Dose or amount: 30 mg milligrams.Frequency: other, once.Route: intra-articular.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER/SEIKAGAKU CORP.
• MDR Report Key: 7628926
• MDR Text Key: 112223197
• Report Number: MW5078007
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541-0300-91
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR