ALIMED RADIATION ATTENUATION GLOVES
Received Dec 18, 2014 · Event occurred Dec 8, 2014
Report 1218386-2014-00002 · MDR key 4360637
Device
Generic name
Radiation Attenuation Gloves
Manufacturer
Alimed, Inc.Model number
PQQ95Catalog number
PQQ95
Lot number
UNK
Product problems
- Improper or Incorrect Procedure or Method
Patient
UNK
- Radiation Burn
Narrative
Additional Manufacturer Narrative
GLOVES ARE MANUFACTURED BY (B)(4). PENDING POSSIBLE ADDITIONAL INFORMATION FROM INITIAL REPORTED (B)(6).
Description of Event or Problem
AS REPORTED BY (B)(6) WAS ASKED BY A DOCTOR TO USE HER FINGERS AS A CLAMP ON THE FEMORAL ARTERY. SHE WAS TOLD TO USE ALIMED RADIATION ATTENUATION GLOVES. (B)(6) CALLED AND ASKED IF IT WAS SAFE TO HAVE HER HANDS WITHIN 2 INCHES OF THE TRANSMITTER. APPARENTLY (B)(6) BURNED THE TIP(S) OF HER FINGERS. ALIMED'S RESPONSE WAS THAT THE GLOVES ARE DESIGNED TO REDUCE SCATTER RADIATION - NOT DIRECT BEAM.