MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for STRYKEFLOW 250-070-500 manufactured by Stryker Corportion.
[125671168]
The suction irrigator was leaking from the hand piece. It did not have a disposable tip. This is a fall/slip hazard for staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8023732 |
| MDR Report Key | 8023732 |
| Date Received | 2018-10-31 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-02 |
| Report Date | 2018-10-24 |
| Date Reported to FDA | 2018-10-24 |
| Date Reported to Mfgr | 2018-10-31 |
| Date Added to Maude | 2018-10-31 |
| 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 | 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 | STRYKEFLOW |
| Generic Name | IRRIGATOR, SUCTION |
| Product Code | LJH |
| Date Received | 2018-10-31 |
| Returned To Mfg | 2018-10-02 |
| Catalog Number | 250-070-500 |
| Lot Number | 18190FG2 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORPORTION |
| Manufacturer Address | 5900 OPTICAL CT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-31 |