MAUDE Adverse Event Report: BIOFEEDBACK MACHINE; DEVICE, BIOFEEDBACK

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

¿ranitidine hcl 150mg rx 7256100 (b)(6).Bloating, weight gain, feeling heavy, horseness, voice not clear.Acetaminophen 500mg, file complaint and how it would be service.Reported tampering med's (b)(6) 2018 pharmacy (b)(6).A lot of conflicting test result, causes more testing experience.¿.

• Brand Name: BIOFEEDBACK MACHINE
• Type of Device: DEVICE, BIOFEEDBACK
• MDR Report Key: 10740263
• MDR Text Key: 213482898
• Report Number: MW5097472
• Device Sequence Number: 2
• Product Code: HCC
• 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

• Date FDA Received: 10/26/2020
• 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
• 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