MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-14 for STRYKEFLOW 250-070-500 manufactured by Stryker Corporation.
[179422005]
Stryker suction irrigator started leaking from the battery housing. Incident discovered prior to affecting patient and device was replaced. Product defect form filled out. Lot # 19234fg2. Ref # 250-070-500.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9711020 |
| MDR Report Key | 9711020 |
| Date Received | 2020-02-14 |
| Date of Report | 2020-01-16 |
| Date of Event | 2020-01-16 |
| Report Date | 2020-01-16 |
| Date Reported to FDA | 2020-01-16 |
| Date Reported to Mfgr | 2020-02-14 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | STRYKEFLOW |
| Generic Name | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
| Product Code | GCX |
| Date Received | 2020-02-14 |
| Catalog Number | 250-070-500 |
| Lot Number | 19234FG2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORPORATION |
| Manufacturer Address | 2825 AIRVIEW BLVD PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |