MAUDE Adverse Event Report: PERSPECTIS, INC. NECK HEAL; HEAD HALTER, TRACTION

Device Problem Difficult to Remove (1528)

Patient Problems Dyspnea (1816); Pain (1994)

Event Date 01/16/2020

Event Type  Injury  

Event Description

Hurt my neck; used the neck heal product from (b)(6) website states it's fda cleared.I put the product on my neck per the instructions and put air into it.I could not take it off quickly and made it hard to breathe.Fda safety report id# (b)(4).

• Brand Name: NECK HEAL
• Type of Device: HEAD HALTER, TRACTION
• Manufacturer (Section D): PERSPECTIS, INC.
• MDR Report Key: 9962148
• MDR Text Key: 187759473
• Report Number: MW5094137
• Device Sequence Number: 1
• Product Code: IRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other