MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-12 for RADIOMETER - COPENHAGEN TCM 3 * manufactured by Radiometer.
[53697]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 79135 |
| MDR Report Key | 79135 |
| Date Received | 1997-02-12 |
| Date of Report | 1996-12-05 |
| Date of Event | 1996-11-07 |
| Date Facility Aware | 1996-11-07 |
| Report Date | 1996-12-05 |
| Date Reported to Mfgr | 1996-12-05 |
| Date Added to Maude | 1997-03-31 |
| 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 |
| 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 | RADIOMETER - COPENHAGEN |
| Generic Name | TRANSCUTANEOUS PO2/PCO2 MONITOR |
| Product Code | KLK |
| Date Received | 1997-02-12 |
| Model Number | TCM 3 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 78742 |
| Manufacturer | RADIOMETER |
| Manufacturer Address | 811 SHARON DR. WESTLAKE OH 44145 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-02-12 |