3M LITTMANN ELECTRONIC STETHOSCOPE
Received Nov 12, 2013 · Event occurred Oct 23, 2013
Report 2110898-2013-00071 · MDR key 3535739
Device
Generic name
Stethoscope, Electronic 870.1875 Dqd
Manufacturer
3m Health CareModel number
3100Catalog number
NA
Lot number
UNK
Product problems
- Insufficient Device Problem Information
Patient
65 YR
- Erythema
- Hypersensitivity/Allergic reaction
- Itching Sensation
- Swelling
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A FEMALE RESPIRATORY THERAPIST, WITH A SEVERE LATEX ALLERGY, REPORTED SHE USED A SOFT BLACK EAR TIP THAT SHE BORROWED FROM HER BOSS AFTER HER SOFT GREY EAR TIP SPLIT. REPORTEDLY, SHE CLEANED IT WITH ALCOHOL BEFORE USING IT ON HER SCOPE. THE USER USED IT IN A PATIENT'S ROOM AND HER EAR BECAME BEET RED, SWOLLEN, STARTED ITCHING AND THE REACTION SPREAD TO HER HEAD, FACE, AND ARM. REPORTEDLY WENT TO THE ER AND WAS TREATED WITH BENADRYL AND DECADRON (IM INJECTION) AND A VISTARIL PRESCRIPTION. USER STATED HER BOSS IS CURRENTLY USING THE BLACK EAR TIP.
Additional Manufacturer Narrative
LOT NUMBER WAS NOT PROVIDED. DEVICE DOES NOT HAVE AN EXPIRATION DATE. ACTUAL USED DEVICE WAS NOT RETURNED. WITHOUT LOT NUMBER, IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE. THIS PRODUCT IS NOT MADE WITH NATURAL RUBBER LATEX.