MAUDE Adverse Event Report: NEUROMONICS INC NEUROMONICS OASIS TINNITUS DEVICE

Model Number OID-00000620

Device Problems Device Operates Differently Than Expected (2913); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Tinnitus (2103)

Event Date 05/26/2015

Event Type  malfunction  

Event Description

Neuromonics oasis tinnitus device causing bilateral inner-ear pressure and worsening tinnitus, as well as worsening hypoacusis.Device of no benefit and appears to be causing harm.Worsening hyperacusis and tinnitus with use of neuromonics oasis tinnitus treatment device.Also causing severe inner ear pressure bilateral.Not effective, of no benefit, and causing harm.Dose, frequency and route used: daily 10 min to 2 hrs.Bilateral ears listening.Therapy dates: daily since (b)(6) 2015.

• Brand Name: NEUROMONICS OASIS TINNITUS DEVICE
• Type of Device: OASIS
• Manufacturer (Section D): NEUROMONICS INC; 8774 yates dr; unit 220; westminster CO 80031
• MDR Report Key: 4939120
• MDR Text Key: 17938446
• Report Number: MW5044715
• 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
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: OID-00000620
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 54