MAUDE Adverse Event Report: STANLEY HEALTHCARE / SECURITAS HEALTHCARE LLC HUGS BAND; SYSTEM, COMMUNICATION, POWERED

Model Number 806A1401

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

Patient Problem Abrasion (1689)

Event Date 02/03/2023

Event Type  Injury  

Event Description

Hugs tag caused 1 cm long abrasion on the ankle.

• Brand Name: HUGS BAND
• Type of Device: SYSTEM, COMMUNICATION, POWERED
• Manufacturer (Section D): STANLEY HEALTHCARE / SECURITAS HEALTHCARE LLC; 4600 vine st.; lincoln NE 68503
• MDR Report Key: 16352912
• MDR Text Key: 309413030
• Report Number: MW5114842
• Device Sequence Number: 1
• Product Code: ILQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 806A1401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 DA
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White