MAUDE Adverse Event Report: BIOVENTUS LLC SUPARTZ FX PFS

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Itching Sensation (1943); Reaction (2414)

Event Date 07/20/2018

Event Type  Injury  

Event Description

Pt stated he spoke to another rep (b)(6) 2018 and informed them of immediate allergic reaction once med was administered: itching at inj site, stiff neck, "major headache" all started at 8:20am.Per pt, md switching him to gelsyn-3 instead.Dose or amount: 25mg, frequency: weekly, route: intra articularly to.Dates of use: from (b)(6) 2018.Diagnosis or reason for use: bilateral primary osteoarthritis of knee.

• Brand Name: SUPARTZ FX PFS
• Type of Device: SUPARTZ FX PFS
• Manufacturer (Section D): BIOVENTUS LLC
• MDR Report Key: 7757506
• MDR Text Key: 116372190
• Report Number: MW5078910
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• 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
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR