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

Device Problems Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Pain (1994); Rash (2033); Swelling (2091)

Event Date 04/17/2017

Event Type  Injury  

Event Description

Patient states she was given a gel-one injection to her left ankle and left foot on (b)(6) 2017 by her orthopedic surgeon, dr.(b)(6).She states on (b)(6) 2017 she developed severe itching to her chest, redness, swelling vasculitis and rashes that spread to both sides of her body and "came together forming welts".She also states she was in a lot of pain.She was treated in the er with steroids and continued treatment for 1 month with topicals, aloe and ice baths.She states she was never asked by her md about her allergy to feathers and that he was also aware that about 1.5 years ago, she had an allergic reaction to a synvisc injection (less severe redness, swelling and rashes) which was given by another md.She states dr.Walker and his nurse practitioner ((b)(6)) and the office patient advocate ((b)(6)) are fully aware and can be contacted for further discussion.She states she was given a complaint form for the synvisc incident (that occurred 1.5 years ago by another md) which she completed but not a complaint form for gel-one.She wants to be contacted by the manufacturer of gel-one (zimmer biomet) and wants to be sent and submit a complaint form to the manufacturer of gel-one.Patient is allergic to feathers.Patient had an allergic reaction 1.5 years ago to synvisc injection - redness, swelling and rashes.Patient wanted to provide her name, address and phone number because she wanted the mfr (zimmer biomet) to be notified of her reaction, wanted a return call from the mfr and a complaint form for her to complete and submit to the manufacturer.Patient's name: (b)(6).Patient also wanted to provide the name and address of the orthopedic surgeon who gave her the injection: dr.(b)(6), (b)(6).Zimmer biomet.Therapy start date: (b)(6) 2017.Primary: yes.

• Brand Name: GEL-ONE
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): SEIKAGAKU CORP - TAKAHAKI PLANT
• MDR Report Key: 7467783
• MDR Text Key: 107021387
• Report Number: MW5076809
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/05/2018

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other