FDA.reportPublic FDA data

MAUDE MDR 164284

MDR report key
164284
Report number
1416900-1998-00021
Event key
0
Event type
3
Date of event
1998-03-01
Date received
1998-04-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACCUFITIMPRESSION MATERIALBELTONE ELECTRONICS CORP.LDGNAA282NAK963958NNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11998-04-2401. R

Event Narratives#

D

Patient 1

THE HEARING AID (H/A) USER CAME INTO THE DISPENSER'S OFFICE WITH A BROKEN HEARING AID. THE DISPENSER MADE AN IMPRESSION OF HER EAR. WHEN THE IMPRESSION WAS REMOVED, THE CLIENT COMPLAINED THAT SHE COULDN'T HEAR AS WELL AS WHEN SHE CAME IN THE OFFICE. CLIENT SAW A DOCTOR WHO DIAGNOSED A PERFORATED LEFT EAR. THE DOCTOR PATCHED THE PERFORATION.