UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-12-22 for UNK * manufactured by Unk.

Event Text Entries

[164925] Rptr was administered an acoustic reflex test on 3/10/98 as part of a compensation claim for tinnitus. A medical audiometry diagnostic device was utilized to administer this test. The test started by the clinician asking rptr to place an intra-aural earphone into the right ear canal. High intensity sound was then introduced into the right ear for an extended period of time. The same procedure was then used on the left ear. Rptr had an immediate and profound sense that his balance was affected and that his ears were stuffy and painful. Both problems still exist seven months later and have had a serious impact upon his life. In addition his eyes now have to compensate for his loss of vestibular function causing him physical exhaustion after being up part of a normal workday. The facility refuses to give rptr any info about their audiology equipment concerning equipment mfr, serial number, model number, calibration info or their safety procedures. Rptr has asked for this info using the freedom of information act. Event has resulted in periodic hospitalization.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015318
• MDR Report Key: 204119
• Date Received: 1998-12-22
• Date of Report: 1998-12-18
• Date of Event: 1998-03-10
• Date Added to Maude: 1999-01-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: UNK
• Generic Name: AUDIOMETRY DIAGNOSTIC DEVICE
• Product Code: EWO
• Date Received: 1998-12-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 198256
• Manufacturer: UNK
• Manufacturer Address: UNK UNK US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other; 3. Deathisabilit	1998-12-22