MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-13 for AIREL IGN 500 manufactured by Airel.
[18475432]
The device is a new product to the dental market that claims to produce "aseptically pure" water in the dental unit. It uses a solution called calbenium as a bacteriostatic, bacteriocidal and virucidal agent that is effective for 100 days. The literature from the mfr suggests the dental unit will produce a sterile spray if the device is used which is suitable for surgery. According to the jada, 10/93, as well as other publications dental unit waterlines are highly contaminated with bacteria due to the presence of a biofilm lining the tubings. A disinfectant solution would need to be extremely potent to remove all bacteria from the biofilm, and if this is true the solution likely would prove toxic to pts. Rptr questions if this calbenium solution has been proven non-toxic and has it been shown to remove biofilm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000486 |
| MDR Report Key | 11051 |
| Date Received | 1994-01-13 |
| Date of Report | 1993-12-28 |
| Date Added to Maude | 1994-01-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AIREL IGN 500 |
| Product Code | EKY |
| Date Received | 1994-01-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11051 |
| Manufacturer | AIREL |
| Manufacturer Address | HIALEAH FL 33014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-13 |