MAUDE Adverse Event Report: SEIKAGAKU CORPORATION TAKANAGI PLANT GEL-ONE 30MG/3ML SYR; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 0019H08G

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

Patient Problem Myocardial Infarction (1969)

Event Date 01/01/2020

Event Type  Injury  

Event Description

Patient reported that she was hospitalized due to heart attack and now has medications.Md: (b)(6); manufacturer name: zimmer.

• Brand Name: GEL-ONE 30MG/3ML SYR
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORPORATION TAKANAGI PLANT
• MDR Report Key: 9829237
• MDR Text Key: 184055536
• Report Number: MW5093733
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541030091
• Combination Product (y/n): Y
• 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: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 0019H08G
• 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: 58 YR