MAUDE Adverse Event Report: AUGMENIX, INC. SPACEOAR HYDROGEL ; HYDROGEL SPACER

Lot Number 07301801

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Rash (2033)

Event Date 08/28/2018

Event Type  Injury  

Event Description

Pt experienced possible allergic reaction after having spaceoar hydrogel insertion.Pt became hypotensive, slurred speech, developed all over the body - rash and nausea with dry heaving.He was admitted to the hospital for observation after continued symptoms.Spaceoar hydrogel , 10 cc unk.Dose or amount: 10 unk, frequency: one time, route: mid point of the prostate gland.Dates of use: (b)(6) 2018.Diagnosis or reason for use: proton therapy.

• Brand Name: SPACEOAR HYDROGEL
• Type of Device: HYDROGEL SPACER
• Manufacturer (Section D): AUGMENIX, INC.
• MDR Report Key: 7842178
• MDR Text Key: 119238654
• Report Number: MW5079526
• Device Sequence Number: 1
• Product Code: OVB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 07301801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Weight: 87