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

Lot Number 0018X05G

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Fainting (1847); Rash (2033); Tingling (2171); Dizziness (2194); Anxiety (2328); Confusion/ Disorientation (2553); No Code Available (3191)

Event Date 03/12/2019

Event Type  Injury  

Event Description

Md's notes: per the pt, after leaving the dept feeling numbness in the knee but otherwise in her usual state of health, she began to feel faint after entering her vehicle in the parking garage.The pt elected to return to the dept and while in the elevator, she reports briefly fainting and noted a warm feeling with pins-and-needles throughout her body.She also reports developing a rash.She reports feeling disoriented as to her exact location, although at the time of my interaction, she was alert and oriented to person, place, and time.She was received by a member of the nursing staff and an office mgr, who called 911 due to the pt's change in condition.Md was notified of the pt's return and came immediately to evaluate the pt.The pt appeared out of breath, but reported feeling anxious.The pt was reassured and after several mins of conversation, her breathing pattern normalized.Redness without hives could be seen along the pt's neck and along the antecubital fossa bilaterally.Vital signs obtained by the nurse can be found in the pt's flow chart and were within normal limits.The pt called and spoke with her daughter on the telephone to update her on her status.At this point, first responders arrived to evaluate the pt who was subsequently taken to the emergency dept for further evaluation.Dose or amount: 3 ml millilitre(s); frequency: once a week; route: intra-articular.Diagnosis or reason for use: oa (osteoarthritis) of knee.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP., TAKAHAGI PLANT
• MDR Report Key: 8425102
• MDR Text Key: 139173591
• Report Number: MW5084950
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/13/2019

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: No Information
• Device Expiration Date: 01/06/2020
• Device Lot Number: 0018X05G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 81