MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-07-02 for NSE FOOTSWITCH 5400007000 manufactured by Stryker Instruments-kalamazoo.
[16990703]
It was reported during testing conducted prior to a procedure at the healthcare facility the device and an exposed wire. There was no surgical delay, medical intervention, adverse consequences or impact on the patient reported with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2015-02395 |
| MDR Report Key | 4888325 |
| Report Source | 06 |
| Date Received | 2015-07-02 |
| Date of Report | 2015-06-09 |
| Date of Event | 2015-06-09 |
| Date Mfgr Received | 2015-06-09 |
| Device Manufacturer Date | 2014-03-10 |
| Date Added to Maude | 2015-07-02 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | 2015-07-02 |
| Returned To Mfg | 2015-06-09 |
| Catalog Number | 5400007000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-07-02 |