MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-09 for TCM3 TINA MONITOR TCM3-2 * manufactured by Radiometer America Inc..
[17107500]
Probe from transcutaneous oxygen monitor burned chest resulting in blister. Setting at 43. 5 degrees c.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 148207 |
| MDR Report Key | 148207 |
| Date Received | 1998-01-09 |
| Date of Report | 1997-07-03 |
| Date of Event | 1997-06-13 |
| Date Facility Aware | 1997-06-23 |
| Report Date | 1997-07-03 |
| Date Added to Maude | 1998-02-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCM3 TINA MONITOR |
| Generic Name | TRANCUTANEOUS OXYGEN MONITOR |
| Product Code | KLK |
| Date Received | 1998-01-09 |
| Model Number | TCM3-2 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 144421 |
| Manufacturer | RADIOMETER AMERICA INC. |
| Manufacturer Address | 810 SHARON DR. WESTLAKE OH 441451598 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-01-09 |