MAUDE Adverse Event Report: SEIKAGAKU CORP GEL - ONE 30MG/3ML PFS; ACID, HYALURONIC

Lot Number 0016409G

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

Patient Problems Itching Sensation (1943); Swelling (2091); Complaint, Ill-Defined (2331); Reaction (2414)

Event Date 03/07/2017

Event Type  Injury  

Event Description

Pt had an allergic reaction to gel-one.Pt was hospitalized on (b)(6) 2017, pt had swollen eyes, itchy skin, and dry mouth.Pt was taken to er from doctor's office.Dose or amount: 30 mg, frequency: once, route: intra-articularly.Dates of use: (b)(6) 2017.Diagnosis: osteoarthritis.Zimmer.

• Brand Name: GEL - ONE 30MG/3ML PFS
• Type of Device: ACID, HYALURONIC
• Manufacturer (Section D): SEIKAGAKU CORP
• MDR Report Key: 6394697
• MDR Text Key: 69756420
• Report Number: MW5068379
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541030091
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/29/2017
• Device Lot Number: 0016409G
• 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: 69 YR