MAUDE Adverse Event Report: TELEHEALTH HEART MONITOR; ELECTROCARDIOGRAPHY TELEMETRIC MONITORING SYSTEM TRANSMITTER

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

Patient Problems Dysphasia (2195); Abdominal Distention (2601); Weight Changes (2607); No Code Available (3191)

Event Type  malfunction  

Event Description

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• Brand Name: TELEHEALTH HEART MONITOR
• Type of Device: ELECTROCARDIOGRAPHY TELEMETRIC MONITORING SYSTEM TRANSMITTER
• MDR Report Key: 10740263
• MDR Text Key: 213482898
• Report Number: MW5097472
• Device Sequence Number: 1
• Product Code: DXH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 111