MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-25 for HUDSON 6203-135 - manufactured by Stryker Corporation.
[134084228]
Stryker hudson modified trinkle (part# 6203-135) is difficult to decontaminate because of the design.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8277169 |
| MDR Report Key | 8277169 |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-11-01 |
| Report Date | 2019-01-03 |
| Date Reported to FDA | 2019-01-03 |
| Date Reported to Mfgr | 2019-01-25 |
| Date Added to Maude | 2019-01-25 |
| 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 | HUDSON |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2019-01-25 |
| Model Number | 6203-135 |
| Catalog Number | - |
| Lot Number | - |
| Device Availability | Y |
| 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 | 2019-01-25 |