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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Pt reported that due to mdo mistake of sending rx somewhere else she was in the hosp in pain because she has been without medication.Arxwp has not dispensed but pt is established on medication.(b)(6).

• Brand Name: GEL ONE 30MG/3ML SYR
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER / SEIKAGAKU CORPORATION, TAKAHAGI PLANT
• MDR Report Key: 12834955
• MDR Text Key: 281029446
• Report Number: MW5105404
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541030091
• 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: 11/12/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Patient Sequence Number: 1
• Treatment: BOTOX; UBRELVY
• Patient Outcome(s): Hospitalization
• Patient Sex: Female