N
Patient 1
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.
MAUDE MDR 5957221
- MDR report key
- 5957221
- Report number
- 0002134751-2016-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-08-15
- Date received
- 2016-09-16
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 403
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- SARAH MOORE
- Address
- 1376 CHEYENNE AVE GRAFTON WI 53024 US
- Phone
- 262-262-2623
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DRY TIPS | SALIVA ABSORBENT | YOUNG MICROBRUSH LLC | KHR | 291543 | 291453 | 27598-1 | N | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-09-16 | 0 |
Event Narratives#
D
Patient 1
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.