BABY QUASAR
Received May 14, 2010 · Event occurred Apr 17, 2010
Report 3006182559-2010-00001 · MDR key 1692102
Device
Generic name
Baby Quasar
Manufacturer
Quasar Bio-tech, Inc.Model number
BQ101Catalog number
NA
Lot number
2225
Product problems
- Use of Device Problem
Patient
Not reported
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
USER ADMITTED SHE FELL ASLEEP WITH THE UNIT ON AND USED THE HEAT DEVICE MUCH LONGER THAN SHE SHOULD HAVE ACCORDING TO THE INSTRUCTIONS FOR USE. WHEN WE ASKED FOR THE PRODUCT TO BE RETURNED, SHE AGREED IF WE WOULD SEND A REPLACEMENT, WHICH WE DID. SHE IS A SATISFIED USER AND WILL CONTINUE TO USE THE BABY QUASAR.
Description of Event or Problem
USER FELL ASLEEP USING THE BABY QUASAR AND WOKE UP THREE HOURS LATER WITH A BLISTERED BURN ON HER CHEEK. SHE APPLIED COLD WATER IMMEDIATELY AND WENT TO THE ER. SHE FOLLOWED UP HER ER VISIT WITH SEVERAL VISITS TO A WOUND CARE SPECIALIST. ON (B) (6) 2010 - ER VISIT. ON (B) (6) 2010 - VISIT TO WOUND CARE SPECIALIST. ON (B) (6) 2010 - VISIT TO WOUND CARE SPECIALIST. ON (B) (6) 2010 - VISIT TO WOUND CARE SPECIALIST.
Remedial action
- Patient Monitoring