inforMED
MalfunctionEPY

BASIS EAR NOSE & THROAT MED-CHECK LIGHT

Received Oct 2, 1999 · Event occurred Aug 4, 1999

Report MW1017299 · MDR key 244335

Device

Generic name

Fiberopitc Light, Magnifier & Ear Speculum

Model number

*

Catalog number

UNK

Lot number

*

Product problems

  • Bent
  • Design/structure problem
  • Disassembly
  • Nonstandard Device
  • Replace

Patient

42 YR

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

ADULT MALE EXAMINED FOR QUESTIONABLE STREPTOCOCCUS INFECTION BY RPTR. RPTR WAS UNABLE TO VISUALIZE THE EAR DRUMS BECAUSE THE EAR SPECULUM AND LIGHT WERE NOT ALIGNED. (RPTR HAD PREVIOUSLY BOUGHT TWO OTHER INSTRUMENTS WHICH HE TRIED ON HIS WIFE AND SON WITH THE SAME RESULTS.) ALSO: TONGUE DEPRESSORS BEND AND ARE USELESS. RPTR URGES THAT THE PRODUCT BE WITHDRAWN FROM THE MARKET. IT IS SOLD IN PHARMACIES. ADD'L EVENT DATE 8/23/99. RPTR WROTE TO MFR ABOUT A DEFECTIVE LIGHT. MFR'S RESPONSE WAS THAT ITS PRODUCTS WERE HIGHLY TESTED AND GUARANTEED ACCURATE. THE KIT RPTR RECEIVED WAS AS A REPLACEMENT. THIS IS THE THIRD KIT RPTR HAS TRIED TO USE AS AN OTOSCOPE. NONE OF THEM PROVIDE LIGHT ON THE TYMPANIC MEMBRANE, USING REGULAR EXAMINATION PROCEDURE OF PULLING THE EARLOBE UPWARD AND POSTERIORLY. RPTR IS TRAINED IN OTOSOCPIC USE. RPTR FEELS THESE KITS ARE USELESS FOR EAR EXAMINATION.