InjuryNYH
GUM RED-COTE
Received Jul 22, 2015 · Event occurred Jul 21, 2015
Report MW5056129 · MDR key 5077501
Device
Generic name
Gum Red-cote
Product problems
- Improper or Incorrect Procedure or Method
- Patient-Device Incompatibility
Patient
3 YR
- Dyspnea
- Swelling
- Anaphylactoid / Anaphylaxis
- Urticaria
- Reaction
Narrative
Description of Event or Problem
MY ALMOST (B)(6) DAUGHTER ATE PART OF A GUM RED-COTE TABLET AND HAD AN ADVERSE ANAPHYLACTIC REACTION. SHE HAD SWELLING OF HER LIPS AND TONGUE, HIVES, AND AN ASTHMA ATTACK. WE TREATED HER WITH BENADRYL AND ALBUTEROL SULFATE VIA NEBULIZER AND THEY BROUGHT HER SYMPTOMS UNDER CONTROL. DATES OF USE: 1 USE. DIAGNOSIS OR REASON FOR USE: TOOTH BRUSHING AID.