MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2011-01-05 for REDSENSE 2010-0208 manufactured by Redsense Medical Inc..
[3000092]
Pt experience venous fistula needle dislodgement which did not set off the attached redsense alarm. Event occurred in outpatient dialysis unit. Pt exhibited his usual restlessness during dialysis but was not confused, agitated or incooperative. The site was not covered. Device has been in use for four months.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2847016 |
| MDR Report Key | 2847016 |
| Report Source | 99 |
| Date Received | 2011-01-05 |
| Date of Report | 2011-01-05 |
| Date of Event | 2011-01-04 |
| Date Facility Aware | 2011-01-04 |
| Report Date | 2011-01-05 |
| Date Reported to FDA | 2011-01-05 |
| Date Reported to Mfgr | 2011-01-04 |
| Date Added to Maude | 2012-11-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REDSENSE |
| Generic Name | REDSENSE ALARM |
| Product Code | ODX |
| Date Received | 2011-01-05 |
| Model Number | 2010-0208 |
| Lot Number | M0100702AA [PATCH] |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | REDSENSE MEDICAL INC. |
| Manufacturer Address | 150 N. MICHIGAN AVENUE STE 1950 CHICAGO IL 60601 US 60601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-05 |