MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for UNK_SUS manufactured by Stryker Sustainability Solutions Lakeland.
[134059952]
The device was not returned to stryker sustainability solutions for evaluation. The reported event originated from a medwatch report and the user facility is unknown. A supplemental mdr will be submitted with the final investigation results. The reported event will continue to be monitored through post-market surveillance.
Patient Sequence No: 1, Text Type: N, H10
[134059953]
It was reported that a pulse oximeter probe was received from critical area and was unable to obtain or maintain patient oxygen saturation d/t. Pulse oximeter probe did not pick up reading. The event report type was reported to be a serious injury and it was reported that intervention was required. However, the event was not reported to be an adverse event. The reported event was submitted through a medwatch form and no follow up is possible as no facility or contact information, serial number or lot number were provided. These are commonly used devices that are readily available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001056128-2019-00008 |
| MDR Report Key | 8276299 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-11-12 |
| Date Mfgr Received | 2019-01-30 |
| Date Added to Maude | 2019-01-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MARISSA RICHMOND |
| Manufacturer Street | 1810 W. DRAKE DRIVE |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal | 85283 |
| Manufacturer Phone | 8888883433 |
| Manufacturer G1 | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Street | 5300 REGION CT |
| Manufacturer City | LAKELAND FL 33815 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33815 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NA |
| Generic Name | NA |
| Product Code | NLF |
| Date Received | 2019-01-24 |
| Catalog Number | UNK_SUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS LAKELAND |
| Manufacturer Address | 5300 REGION CT LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-24 |