DRY TIPS
Received Sep 16, 2016 · Event occurred Aug 15, 2016
Report 0002134751-2016-00001 · MDR key 5957221
Device
Generic name
Saliva Absorbent
Manufacturer
Young Microbrush LlcModel number
291543Catalog number
291453
Lot number
27598-1
Product problems
- Patient-Device Incompatibility
Patient
Not reported
- Erythema
- Hypersensitivity/Allergic reaction
- Swelling
- Reaction
- Erythema
- Hypersensitivity/Allergic reaction
- Swelling
- Reaction
Narrative
Additional Manufacturer Narrative
IT WAS CONFIRMED THAT THE PRODUCT DID NOT CONTAIN ANY OF THE ITEMS THAT THE PATIENT WAS REPORTED TO BE ALLERGIC TO. PRODUCT NOT AVAILABLE FOR RETURN.
Description of Event or Problem
THE DENTIST REPORTS AN ALLERGIC REACTION OF A PATIENT AFTER "DRY TIPS SMALL" HAVE BEEN PUT IN THE PATIENTS MOUTH. (REF NO.: 291543; BATCH: 275981). THE PATIENT GOT A LOCAL ANESTHESIA WITH ULTRACAIN DS FORTE. APPROXIMATELY 45MIN LATER IN THE PROCEDURE THE DRY TIP HAS BEEN PUT INTO THE PATIENTS MOUTH AND IMMEDIATELY AFTER THAT, THE LEFT HALF OF THE FACE BEGAN TO SWELL AND GOT REDDENED (ERYTHEMA). THE REACTION WAS VISIBLE ON THE LEFT SIDE OF THE FACE UP TO THE PATIENTS EYE. THE DENTIST TOOK OUT THE DRY TIP IMMEDIATELY AND COOLED THE FACE, WHICH REDUCED THE SWELLING A LITTLE. IN ADDITION AN AMBULANCE HAS BEEN CALLED. IT WAS KNOWN THAT THE PATIENT HAS A LATEX AND A WOOD RESIN ALLERGY. THEREFORE THE PATIENT WAS TREATED LATEX-FREE.