MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-01-07 for TEMPSPAN GLAZE N69G manufactured by Pentron Clinical.
[3109360]
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 second of two (2) reports.
Patient Sequence No: 1, Text Type: D, B5
[10497101]
Patient specifics with regard to age, gender, and weight were not provided by the doctor. The patient experienced a reaction with symptoms of swollen lips and mouth sores. The doctor prescribed dexamethasone rinse, chlorhexadine rinse (periogard), kenalog in orabase, benadryl, and chloroseptic 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 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2024312-2013-00003 |
| MDR Report Key | 2898261 |
| Report Source | 05 |
| Date Received | 2013-01-07 |
| Date of Report | 2012-12-06 |
| Date Mfgr Received | 2012-12-06 |
| Device Manufacturer Date | 2012-01-05 |
| Date Added to Maude | 2013-01-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS. WENDY |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167602 |
| Manufacturer G1 | PENTROL CLINICAL |
| Manufacturer Street | 1717 WEST COLLINS AVENUE |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92867 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEMPSPAN GLAZE |
| Generic Name | DENTURE RELINING, REPAIRING, OR REBASING RESIN |
| Product Code | EBI |
| Date Received | 2013-01-07 |
| Catalog Number | N69G |
| Lot Number | 4417290 |
| Device Expiration Date | 2013-12-01 |
| Operator | DENTIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENTRON CLINICAL |
| Manufacturer Address | 1717 WEST COLLINS AVENUE ORANGE CA 92867 US 92867 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2013-01-07 |