MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-11-22 for NSE FOOTSWITCH 5400007000 manufactured by Stryker Instruments-kalamazoo.
[60628525]
The user facility reported that wires were exposed during testing. The user facility did not report any adverse events related to this event.
Patient Sequence No: 1, Text Type: D, B5
[65395645]
Manufacturer report number 0001811755-2016-02773 was filed in error. Additional information regarding the event clarified that the customer did not experience a reportable event per 21 cfr 803:20.
Patient Sequence No: 1, Text Type: N, H10
[65395646]
The user facility reported that wires were exposed during testing. The user facility did not report any adverse events related to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2016-02773 |
| MDR Report Key | 6120056 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-11-22 |
| Date of Report | 2017-01-19 |
| Date of Event | 2016-10-28 |
| Date Mfgr Received | 2017-01-12 |
| Device Manufacturer Date | 2015-05-12 |
| Date Added to Maude | 2016-11-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NSE FOOTSWITCH |
| Generic Name | DRIVER, WIRE, AND BONE DRILL, MANUAL |
| Product Code | DZJ |
| Date Received | 2016-11-22 |
| Returned To Mfg | 2016-11-01 |
| Catalog Number | 5400007000 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-22 |