MAUDE Adverse Event Report: PHONAK PHONAK "HEARING AID MASKERS"

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Sleep Dysfunction (2517)

Event Type  Injury  

Event Description

Sleeplessness, insomnia, diarrhea.

• Brand Name: PHONAK "HEARING AID MASKERS"
• Type of Device: PHONAK "HEARING AID MASKERS"
• Manufacturer (Section D): PHONAK
• MDR Report Key: 4895179
• MDR Text Key: 15135418
• Report Number: MW5043596
• Device Sequence Number: 1
• Product Code: KLW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2015
• Patient Sequence Number: 1
• Treatment: IBUPROFEN 800MG TAB LEG; PROCTO FOAM HCL% AERMED; ESCI TAB PRAM 5 MG TAB IEV; QUETIAPINE FUMARATE 100MG TAB ACC; OPEPRAZOLE 20 MG CAP APO
• Patient Outcome(s): Disability
• Patient Age: 18 YR
• Patient Weight: 160