MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for JACK SCALER R138 manufactured by Pdt, Inc..
[177883777]
Catastrophic instrument failure of approximately 20-30 instruments, purchased since 2018. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092728 |
| MDR Report Key | 9665595 |
| Date Received | 2020-02-03 |
| Date of Report | 2020-01-30 |
| Date of Event | 2020-01-30 |
| Date Added to Maude | 2020-02-04 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JACK SCALER |
| Generic Name | SCALER, PERIODONTIC |
| Product Code | EMN |
| Date Received | 2020-02-03 |
| Model Number | R138 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PDT, INC. |
| Manufacturer Address | MISSOULA MT 59808 US 59808 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |