MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-07 for UNK manufactured by Aseptico.
[353070]
According to rptr, mfr's two products for use in dentistry in a warehouse environment without any physical systems in place to prevent contamination. The products are rubber dams and tips for injecting thermal elastomer in nerve canals.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1032950 |
| MDR Report Key | 551824 |
| Date Received | 2004-08-07 |
| Date of Report | 2004-08-07 |
| Date of Event | 2004-02-02 |
| Date Added to Maude | 2004-10-28 |
| 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 | 3 |
| 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 | UNK |
| Generic Name | RUBBER DAM, TIP FOR INJECTING THERMAL ELASTYMER |
| Product Code | EIE |
| Date Received | 2004-08-07 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 541351 |
| Manufacturer | ASEPTICO |
| Manufacturer Address | 8333 216TH ST., S.E. WOODINVILLE WA 98072 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-07 |