MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-24 for FIRST STEP BEDSIDE PRECLEAN KIT TK200 manufactured by Cygnus Medical.
[5554333]
A few weeks ago it was reported by my facility's infectious disease physician that there was a notable uptake in stenotrophomonas maltophilia seen in bronchoscopy cases, particularly washes and lavages, based on a series of lab results returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5041020 |
| MDR Report Key | 4563426 |
| Date Received | 2015-02-24 |
| Date of Report | 2015-02-24 |
| Date of Event | 2015-02-24 |
| Date Added to Maude | 2015-03-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FIRST STEP BEDSIDE PRECLEAN KIT |
| Generic Name | PRECLEAN KIT |
| Product Code | JCB |
| Date Received | 2015-02-24 |
| Model Number | TK200 |
| Lot Number | EX20150514A |
| Device Expiration Date | 2015-05-14 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYGNUS MEDICAL |
| Brand Name | FIRST STEP BEDSIDE PRECLEAN KIT |
| Generic Name | PRECLEAN KIT |
| Product Code | JCB |
| Date Received | 2015-02-24 |
| Model Number | TK200 |
| Lot Number | EX20160712A |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | CYGNUS MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-24 |