MAUDE Adverse Event Report: HILL IFC HILL IFC

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

Patient Problem Burn, Thermal (2530)

Event Date 12/15/2019

Event Type  Injury  

Event Description

Pt went to er after therapy treatment at our office to right shoulder for burn injury.Pt treated and released.Device taken out of treatment area not in.Not as of (b)(6) 2019.

• Brand Name: HILL IFC
• Type of Device: HILL IFC
• Manufacturer (Section D): HILL IFC
• MDR Report Key: 9829647
• MDR Text Key: 184639258
• Report Number: 9829647
• Device Sequence Number: 1
• Product Code: GZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/06/2019,11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/10/2019
• Distributor Facility Aware Date: 01/06/2019
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/10/2019
• 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): Other
• Patient Age: 60 YR
• Patient Weight: 50