OtherIWY

MED-TEC UNI-FRAME

Received Jan 24, 2001 · Event occurred Jan 14, 2001

Report 1932738-2001-00001 · MDR key 313833

Device

Generic name

Radiographic Head Holder

Manufacturer

Med-tec,inc.

Model number

MT-APU-14

Catalog number

MT-APU-14

Lot number

19082

Product problems

Reaction

Patient

Rash

Narrative

Description of Event or Problem

THE PT WAS TREATED WITH SHELL LAST DECEMBER AND CLAIMED ALLERGY TO DEVICE. RASH APPEARED BETWEEN LIP AND JAW ORIGINALLY AND THEN APPEARED ON WHOLE BODY. MED-TEC'S UNI-FRAME SHELL WAS USED AND THE PT HAD A SIMILAR REACTION.