FDA.report

MAUDE MDR 9713232

MDR report key
9713232
Report number
2183646-2020-00002
Event key
0
Event type
3
Date of event
2020-01-30
Date received
2020-02-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Related Records

Manufacturer Contact

Contact
MR. BRENT GEIGER
Address
13700 1ST AVE. N PLYMOUTH, MN US
Phone
577-577-5772
Report source
M
Manufacturer link flag
Y

Devices

SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1NONIN WRISTOX2 PULSE OXIMETERWRIST-WORN PULSE OXIMETERNONIN MEDICAL, INC.DQA3150110204-001R N

Patients

SequenceReceivedTreatmentOutcome
12020-02-1401. O

Event Narratives

N

Patient 1

REGARDING PATIENT INFORMATION, NOTHING FURTHER HAS BEEN DISCLOSED TO NONIN. PREEXISTING MEDICAL CONDITIONS COULD NOT BE DETERMINED. NONIN IS WAITING ON THE RETURN OF THE DEVICE, AND ONCE RECEIVED, WILL SUBJECT IT TO INVESTIGATION AND TESTING.

D

Patient 1

THE PATIENT DESCRIBED GOING TO BED AROUND 10-11 PM, AND WAS AWAKEN BY A BURNING SENSATION AROUND 3-4 AM. HE THEN TOOK OFF THE DEVICE AND PLACED ICE CUBES ON THE BURN SITE, HIS RIGHT WRIST.

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06946725550182APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550199APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550205APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550212APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550229APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550236APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550243APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550250APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550267APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550274APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550281APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550298APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550304APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725550311APKAPK Technology Co.,Ltd.DQA2026-03-19

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TypeSubmissionProduct codeDeviceApplicantDecision date
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510(k)K260931DQAUnimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.2026-04-14
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510(k)K252805DQAYUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.2026-02-17