MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-28 for 260010 manufactured by Steris Corporation.
[93050804]
Patient Sequence No: 1, Text Type: N, H10
[93050805]
Steam sterilization in central sterile/sterile processing was completed using required indicator tape for blue wrapped instruments. This tape did not change as required for validation of sterilization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7062842 |
| MDR Report Key | 7062842 |
| Date Received | 2017-11-28 |
| Date of Report | 2017-11-15 |
| Date of Event | 2017-11-10 |
| Report Date | 2017-11-13 |
| Date Reported to FDA | 2017-11-13 |
| Date Reported to Mfgr | 2017-11-13 |
| Date Added to Maude | 2017-11-28 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | NA |
| Generic Name | INDICATOR, PHYSICAL/CHEMICAL STERILIZATION PROCESS |
| Product Code | JOJ |
| Date Received | 2017-11-28 |
| Model Number | 260010 |
| Catalog Number | 260010 |
| Lot Number | 709401 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION |
| Manufacturer Address | 5960 HEISLEY ROAD MENTOR OH 44060 US 44060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-28 |