MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-20 for NOX T3, NOXTURNAL T3 SLEEP MONITOR 22857-001 manufactured by Nox Medical.
[45640688]
Carefusion file identification: (b)(4). Importer report number: (b)(4). (b)(4). Carefusion is the importer of record for this device. The legal manufacturer (nox medical) has been notified of the reported event. Any further reports will come from the legal manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[45640689]
The customer reported one of their patients complained of a burning sensation after wearing the nonin 3150 pulse oximeter for approximately two hours during an in home sleep study. The patient removed the device and found that the area on the patient's skin under were the batteries are inserted had redness and a blister. The patient went to urgent care and was treated with an antibiotic and a cream for the burn. The device was returned to the customer by the patient and the patient was sent to a clinic for the completion of the sleep study.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03768 |
| MDR Report Key | 5670703 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-20 |
| Date of Report | 2016-04-21 |
| Date of Event | 2016-04-21 |
| Date Facility Aware | 2016-04-21 |
| Report Date | 2016-05-20 |
| Date Reported to FDA | 2016-05-20 |
| Date Reported to Mfgr | 2016-05-20 |
| Date Mfgr Received | 2016-04-21 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2016-05-20 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | NOX MEDICAL |
| Manufacturer Street | IMPRA KELDNAHOLTI IS 112 |
| Manufacturer City | REYKJAVIK |
| Manufacturer Country | IC |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOX T3, NOXTURNAL |
| Generic Name | VENTILATORY EFFORT RECORDER |
| Product Code | MNR |
| Date Received | 2016-05-20 |
| Returned To Mfg | 2016-05-11 |
| Model Number | T3 SLEEP MONITOR |
| Catalog Number | 22857-001 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOX MEDICAL |
| Manufacturer Address | IMPRA KELDNAHOLTI IS112 REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-20 |