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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dyspnea (1816)

Event Date 11/14/2019

Event Type  Injury  

Event Description

Neck heal product was filled with air and i could not breathe properly because it was tight around my neck and did not release.Also i called to complain and was told that the neck heal from (b)(6) is fda cleared.There is an fda symbol on (b)(6).Fda safety report id# (b)(4).

• Brand Name: NECK HEAL
• Type of Device: HEAD HALTER, TRACTION
• Manufacturer (Section D): PERSPECTIS INC.
• MDR Report Key: 9410675
• MDR Text Key: 169212473
• Report Number: MW5091411
• 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: 11/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 61