MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for MAX-A manufactured by Stryker Sustainability Solutions, Inc..
[134886268]
Male patient had a cardiac catheterization and pci (groin approach) in the cardiac cath lab. A stryker max-a pulse oximeter sensor was placed on his left index finger pre-procedure and remained on his finger until he was discharged home approximately eight hours later. The patient contacted the facility about one week later stating that he was experiencing a neuro deficit (numbness) in the tip of the left index finger where the pulse oximeter sensor had been attached. As of (b)(6) 2018, the patient reported that he has about 80-85% of his feeling back in the left index finger (tip). His cardiologist will see him again in two months and he will report his status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8300802 |
| MDR Report Key | 8300802 |
| Date Received | 2019-02-04 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-11-06 |
| Report Date | 2019-01-29 |
| Date Reported to FDA | 2019-01-29 |
| Date Reported to Mfgr | 2019-02-04 |
| Date Added to Maude | 2019-02-04 |
| 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 |
| Generic Name | OXIMETER, REPROCESSED |
| Product Code | NLF |
| Date Received | 2019-02-04 |
| Model Number | MAX-A |
| Catalog Number | MAX-A |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS, INC. |
| Manufacturer Address | 5300 REGION CT LAKELAND FL 33815 US 33815 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-04 |