MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-14 for STERIS RELIANCE 6000 RECT1CON20 manufactured by Steris Canada Ulc.
[175480370]
Steris reliance 6000 endoscope drying cabinet tubing sets sterilized following the ifu from the mfr became melted with small pieces of hard clear plastic breaking off and present throughout the tubing after sterilizing. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092247 |
| MDR Report Key | 9592545 |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-10 |
| Date of Event | 2020-01-02 |
| Date Added to Maude | 2020-01-15 |
| 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERIS RELIANCE 6000 |
| Generic Name | UNIT, DRYING |
| Product Code | JRJ |
| Date Received | 2020-01-14 |
| Model Number | RECT1CON20 |
| Catalog Number | RECT1CON20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CANADA ULC |
| Manufacturer Address | COLUMBUS OH 43228 US 43228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |