MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-02 for NOX T3, NOXTURNAL T3 SLEEP MONITOR 22857-001 manufactured by Nox Medical.
[46468074]
(b)(4). Importer report number: (b)(4). (b)(4). (b)(4) 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
[46468075]
The customer reported one of their patients complained that the device on the wrist became hot around 2am and the patient awoke to a burning sensation and noticed redness on his arm with a small area of wetness. He immediately took off the device and noted fluid residue on his arm. He washed his arm for three to five minutes and then applied neosporin and a dressing to the area. The patient then went back to sleep and was awakened to slight discomfort in the area he had washed. The patient then washed the area again and noted a scab forming. When the patient woke up later that day he went to a clinic and was treated by a nurse practitioner who stated that the patient had a second degree burn from the heat of the device. The burn was in a rectangular shape with a blackish stain, it was approximately 2. 5 inches by 0. 5 inches on the anterior of the arm, approximately 3 inches from the wrist. The patient's arm was cleaned by the nurse practitioner and neosporin and a couple of 2x2 dressings were applied to the site along with coban to secure the dressing. The patient was then sent home and instructed to go to the emergency room if they noticed any signs of infection. The patient has since reported that they are healing just fine. 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 | 2021710-2016-03823 |
| MDR Report Key | 5696161 |
| Date Received | 2016-06-02 |
| Date of Report | 2016-05-11 |
| Date of Event | 2016-05-11 |
| Date Facility Aware | 2016-05-11 |
| Report Date | 2016-06-02 |
| Date Reported to FDA | 2016-06-02 |
| Date Reported to Mfgr | 2016-05-13 |
| Date Mfgr Received | 2016-05-11 |
| Device Manufacturer Date | 2014-09-01 |
| Date Added to Maude | 2016-06-02 |
| 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 |
| 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 | 7149227830 |
| 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 | 0 |
| Brand Name | NOX T3, NOXTURNAL |
| Generic Name | VENTILATORY EFFORT RECORDER |
| Product Code | MNR |
| Date Received | 2016-06-02 |
| Returned To Mfg | 2016-05-31 |
| 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 | 2016-06-02 |