MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-12 for WAGNER STERISET 1.4404 MDD 93/42/EWG manufactured by Wagner Gmbh.
[130048660]
Upon completion of a surgery it was noted that the condensate drain valve from the steriset container had been missing since the sterilization process. This was not discovered because the automatic thermoloc sealed successfully as noted by the red blocks. Currently there is no indicator for when the valve is missing or even if there is an insufficient seal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8154653 |
| MDR Report Key | 8154653 |
| Date Received | 2018-12-12 |
| Date of Report | 2018-12-05 |
| Date of Event | 2018-09-28 |
| Report Date | 2018-12-05 |
| Date Reported to FDA | 2018-12-05 |
| Date Reported to Mfgr | 2018-12-12 |
| Date Added to Maude | 2018-12-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | WAGNER STERISET |
| Generic Name | STERILIZATION TRAY |
| Product Code | FRG |
| Date Received | 2018-12-12 |
| Model Number | 1.4404 |
| Catalog Number | MDD 93/42/EWG |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WAGNER GMBH |
| Manufacturer Address | SIMCON INTERNATIONAL LLC 1200 TOWNLINE ROAD MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-12 |