K-Y TOUCH MASSAGE 2 IN 1 WARMING USA
Received Aug 4, 2011 · Event occurred Jul 6, 2011
Report 2214133-2011-00003 · MDR key 2197005
Device
Product problems
- Patient-Device Incompatibility
Patient
35 YR
- Hypersensitivity/Allergic reaction
- Respiratory Distress
- Swelling
- Urticaria
Narrative
Additional Manufacturer Narrative
DATE OF THIS SUBMISSION IS (B)(6) 2011. THIS CLOSES OUT THIS REPORT UNLESS ADDITIONAL SIGNIFICANT INFO IS RECEIVED.
Description of Event or Problem
CONSUMER REPORTS THAT SHE EXPERIENCED SWELLING OF HER THROAT AND TONGUE, ITCHING AND HIVES AFTER THE SECOND APPLICATION OF THIS PRODUCT. CONSUMER WAS TAKEN TO THE HOSPITAL BY AMBULANCE. SHE WAS ADMINISTERED CPR AND ADMITTED TO THE ICU ONCE HER BREATHING RETURNED TO NORMAL. IN THE HOSPITAL SHE WAS TREATED WITH HYDROCORTISONE, STEROIDS, EPINEPHRINE, AND UNSPECIFIED BREATHING TREATMENTS. THE FIRST TIME SHE USED THIS PRODUCT ((B)(6) 2010) SHE EXPERIENCED A MILD REACTION AND WAS TREATED AT IN THE EMERGENCY DEPARTMENT.