InjuryMMS
K-Y WARMING LIQUID
Received Oct 11, 2004 · Event occurred May 1, 2004
Report 2214133-2004-00001 · MDR key 548424
Device
Generic name
Personal Lubricant
Manufacturer
Personal Products Co.Model number
NACatalog number
NA
Lot number
UNK
Product problems
- Unknown (for use when the device problem is not known)
Patient
34 YR
- Anaphylactic Shock
- Hives
- Itching Sensation
- Swelling
- Other (for use when an appropriate patient code cannot be identified)
- Loss of consciousness
- Sweating
- Therapy/non-surgical treatment, additional
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
CONSUMER'S SPOUSE REPORTED THAT 10 MINUTES AFTER CONSUMER USED CO'S PRODUCT THEY DEVELOPED HIVES AND ITCHING ALL OVER, SWEATING, STAGGERING, SWELLING OF FACE, CLOSING OF THROAT AND LOSS OF CONSCIOUSNESS FOR 10 MINUTES. RESCUE SQUAD WAS CALLED. TWO INTRAVENOUS CATHETERS WERE INSERTED, AN ELECTROCARDIOGRAM WAS DONE, OXYGEN WAS ADMINISTERED AND EPINERPHRINE WAS GIVEN TWICE. CONSUMER WAS HOSPITALIZED OVERNIGHT AND STATES THEIR DIAGNOSIS WAS ANAPHYLACTIC SHOCK. THIS INCIDENT OCCURRED DURING INTERCOURSE.