InjuryKMJ
ASTROGLIDE
Received Sep 30, 1998 · Event occurred Aug 27, 1998
Report 2025771-1998-00001 · MDR key 190428
Device
Generic name
Personal Lubricant
Manufacturer
Biofilm, Inc.Model number
NACatalog number
NA
Lot number
97328
Product problems
- Reaction
Patient
42 YR
- Allergic reaction
- Erythema
- Swelling
- Other (for use when an appropriate patient code cannot be identified)
- Sneezing
- Breathing difficulties
- Choking
- Treatment with medication(s)
Narrative
Description of Event or Problem
PT HAD A REACTION TO ASTROGLIDE WHILE USING IT ANALLY. IMMEDIATELY AFTER USING ASTROGLIDE, PT BEGAN TO COUGH, SNEEZE AND CHOKE. WITHIN MINS, PT'S FACE AND THROAT SWELLED AND BECAME RED. IT WAS ALSO DIFFICULT TO BREATHE. PT WENT TO THE EMERGENCY ROOM VIA CAR AND WAS TREATED WITH AN INJECTION OF BENADRYL. THE DR TOLD PT THAT IT WAS A ALLERGIC REACTION TO PROPYLPARABEN. PT WAS RELEASED FROM THE EMERGENCY ROOM 2 HRS AFTER ARRIVING. PT SAID THAT NO DR FOLLOW-UP WAS NECESSARY.