FDA Adverse Event
Death
Summary report: N
NELLCOR
MDR report key: 6323333
·
Received February 10, 2017
Report
- Report Number
- 2936999-2017-00098
- Event Type
- Death
- Date Received
- February 10, 2017
- Report Date
- January 20, 2017
- Manufacturer
- TIJUANA-RX
- Product Code
- DQA
- PMA / PMN Number
- K904039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER. NO MANUFACTURE DATE CAN BE DETERMINED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER USE OF THE SENSOR, A "STAGE 3 DEEP TISSUE INJURY" OCCURRED. THE NURSE ALSO STATED THAT THE WOUND WAS "ISCHEMIC TISSUE¿ WITH LITTLE SCARRING AND HEALED WITH WOUND CARE. THE CUSTOMER REPORTED THAT THE PATIENT WAS VERY ILL AND LATER EXPIRED AND THAT THE EXPIRING WAS NOT RELATED TO THE SENSOR OR FOREHEAD WOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105766 | NELLCOR | REFLECTANCE SENSOR | DQA | TIJUANA-RX | RS10 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |