MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-06 for BEST NOMOS STP 110 PRECISION STEPPER manufactured by Best Nomos.
[129883199]
Best nomos stp 110 precision stepper has unclear instructions on how to clean and disinfect the device. (b)(6), who works at the company, stated that the device does not need to be sterilized, but there are no clear instructions on how to clean the device if it is not sterilized. I asked him to email me instructions and he said he would have to talk to the legal dept. There is a device that is already being used in the hosp. How can they not have clear instructions if the device is already on the market.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081935 |
| MDR Report Key | 8142249 |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-12-05 |
| Date Added to Maude | 2018-12-07 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | BEST NOMOS STP 110 PRECISION STEPPER |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE MANUAL |
| Product Code | IWJ |
| Date Received | 2018-12-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BEST NOMOS |
| Manufacturer Address | PITTSBURGH PA 15202 US 15202 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-06 |