inforMED
MalfunctionIMC

THERABATH

Received Mar 14, 1997 · Event occurred Nov 1, 1996

Report MW1010958 · MDR key 76213

Device

Generic name

Parafin Heat Therapy System

Model number

TB5

Catalog number

*

Lot number

*

Product problems

  • False claim
  • Output, low
  • Inadequate Service

Patient

58 YR

  • Therapeutic Response, Decreased

Narrative

Description of Event or Problem

DEVICE WAS PRESCRIBED FOR THUMB PAIN FROM ARTHRITIS. DEVICE WAS PURCHASED AND DID NOT GENERATE SUFFICIENT HEAT TO PENETRATE AS IT WAS SUPPOSED TO. THE UNIT WAS EXCHANGED FOR ANOTHER WHICH ALSO FAILED TO GENERATE SUFFICIENT HEAT. (A HOT WATER SOAK FROM THE TAP WAS FAR SUPERIOR). ALTHOUGH THE MFR GUARANTEES (LIFETIME) THE PRODUCT AND EVENT WAS REPORTED WITHIN DAYS, NEITHER THE RETAILER NOR THE MFR WOULD REFUND THE MONEY OR ALLOW THE RETURN.