MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-12-30 for ENDO ICE * H05032 manufactured by Coltene/whaledent Inc..
[16399268]
Dr called and reported of having been practicing dentistry for seventeen years; that dr uses endo ice for diagnostic testing of teeth (to determine tooth vitality) and also to treat muscle spasms by spraying the cold material to the affected area; this sort of shocks the spasm and it stops. Dr reported that, on 7 december 1999, dr used this process with endo ice (batch no. G109-9909-1401) on a pt, generally in good health. According to the dr, this treatment unfortunately resulted in the pt receiving an apparently severe frost bite on the cheek. At the time of the subject telcon, dr was concerned with the healing of this frost bite and recommended that the pt see a plastic surgeon. When co rep asked if the dr thought that there might be anything wrong with the can/container, he indicated that there was nothing wrong with the can and that dr's only reason for calling was not to fault anyone, but to point out to the co, coltene/whaledent inc. , that co should consider to make the caution notice more prominent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2416455-1999-00003 |
| MDR Report Key | 257279 |
| Report Source | 05 |
| Date Received | 1999-12-30 |
| Date of Report | 1999-12-30 |
| Date of Event | 1999-12-07 |
| Date Added to Maude | 2000-01-05 |
| 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 | 0 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 750 CORPORATE DR |
| Manufacturer City | MAHWAH NJ 074302009 |
| Manufacturer Country | US |
| Manufacturer Postal | 074302009 |
| Manufacturer Phone | 2015128000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDO ICE |
| Generic Name | TOOTH VITALITY TESTER |
| Product Code | EAT |
| Date Received | 1999-12-30 |
| Model Number | * |
| Catalog Number | H05032 |
| Lot Number | G109-9909-1401 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 249143 |
| Manufacturer | COLTENE/WHALEDENT INC. |
| Manufacturer Address | 750 CORPORATE DR. MAHWAH NJ 074302009 US |
| Baseline Brand Name | ENDO ICE |
| Baseline Generic Name | TOOTH VITALITY TESTER |
| Baseline Model No | * |
| Baseline Catalog No | H05032 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-12-30 |