FDA Adverse Event
Injury
Summary report: N
RADIOMETER - COPENHAGEN
MDR report key: 79135
·
Received February 12, 1997
Report
- Report Number
- 79135
- Event Type
- Injury
- Date Received
- February 12, 1997
- Date of Event
- November 7, 1996
- Report Date
- December 5, 1996
- Manufacturer
- RADIOMETER
- Product Code
- KLK
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
BURNS DISCOVERED ON RIGHT AND LEFT UPPER CHEST AREA UNDER TRANSCUTANEOUS MONITOR SITE. BACITRACIN ORDERED. RESPIRATORY WAS CHANGING SITES EVERY 4 HRS. NURSING TOOK OVER AND CHANGED SITES EVERY 2 HRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RADIOMETER - COPENHAGEN | TRANSCUTANEOUS PO2/PCO2 MONITOR | KLK | RADIOMETER | TCM 3 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |