D
Patient 1
A DOCTOR ALLEGED THAT TWO (2) PATIENTS EXPERIENCED A REACTION WITH SYMPTOMS OF SWOLLEN LIPS AND MOUTH SORES AFTER THE USE OF TEMPSPAN GLAZE. THIS IS THE FIRST OF TWO (2) REPORTS.
MAUDE MDR 2898227
- MDR report key
- 2898227
- Report number
- 2024312-2013-00002
- Event key
- 0
- Event type
- 3
- Date received
- 2013-01-07
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MRS. WENDY
- Address
- 1717 WEST COLLINS AVENUE ORANGE CA 92867 US
- Phone
- 714-714-7145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TEMPSPAN GLAZE | DENTURE RELINING, REPAIRING, OR REBASING RESIN | PENTRON CLINICAL | EBI | N69G | 4417290 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-01-07 | 0 | 1. O; 2. R |
Event Narratives#
N
Patient 1
PATIENT SPECIFICS WITH REGARD TO AGE AND WEIGHT WERE NOT PROVIDED BY THE DOCTOR. THE PATIENT EXPERIENCED A REACTION WITH SYMPTOMS OF SWOLLEN LIPS APPROXIMATELY THREE (3) TIMES THEIR NORMAL SIZE AND MOUTH SORES. THE PATIENT RETURNED TO THE DOCTOR'S OFFICE THE NEXT DAY WITH REGARD TO THESE SYMPTOMS; THE DOCTOR PRESCRIBED DEXAMETHASONE RINSE, CHLORHEXIDINE RINSE (PERIOGARD), KENALOG IN ORABASE, BENADRYL, AND CHLORASEPTIC FOR TREATMENT. TO DATE, THE PATIENT HAS FULLY RECOVERED AND IS DOING FINE. A VISUAL INSPECTION AND CURING TEST WERE PERFORMED ON THE RETURNED PRODUCT, YIELDING RESULTS WITHIN SPECIFICATIONS. A DHR REVIEW INDICATED THAT THERE WERE NO DEVIATIONS FROM THE MANUFACTURING PROCESS. IN ADDITION, NO SIMILAR COMPLAINTS WERE RECEIVED WITH REGARD TO THIS LOT. IT WAS REVEALED TO PENTRON TECHNICAL SERVICE THAT THE DOCTOR DID NOT ISOLATE THE TISSUE AREA AND DID NOT LIGHT CURE THE PRODUCT FOR THE PERIOD OF TIME REQUIRED AS PER THE DIRECTIONS FOR USE. THE DIRECTIONS STATE THAT THE PRODUCT MUST BE LIGHT CURED ON EACH SURFACE OF THE PROVISIONAL FOR THIRTY (30) SECONDS. THE DIRECTIONS ALSO STATE: "UNCURED METHACRYLATE RESIN MAY CAUSE CONTACT DERMATITIS AND DAMAGE THE PULP. AVOID CONTACT WITH SKIN, EYES AND SOFT TISSUE." THESE INVESTIGATION RESULTS INDICATE THAT THIS INCIDENT IS AN ISOLATED INCIDENT THAT OCCURRED AS A RESULT OF A USER/TECHNIQUE RELATED ISSUE AND WAS NOT DUE TO A PRODUCT FAILURE.