MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-10 for TC PO2/PCO2 ELECTRODE 945-377 manufactured by Radiometer Medical Aps.
[132810840]
Date of event: is estimated based on manufacturer awareness date. It is presently unknown whether it was a healthcare professional handling the patient. However, it is not possible to mark 'no information. '
Patient Sequence No: 1, Text Type: N, H10
[132810841]
According to the complaint, the skin of the patient was slightly burned during transcutaneous oxygen/carbon dioxide measurement ultimately leaving a red mark and a blister.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2019-00001 |
| MDR Report Key | 8234891 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-10 |
| Date of Report | 2019-03-19 |
| Date of Event | 2018-12-24 |
| Date Mfgr Received | 2019-03-07 |
| Device Manufacturer Date | 2016-09-14 |
| Date Added to Maude | 2019-01-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. SOEREN MADSEN |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal | 2700 |
| Manufacturer G1 | RADIOMETER MEDICAL APS |
| Manufacturer Street | AAKANDEVEJ 21 |
| Manufacturer City | BROENSHOEJ, 2700 |
| Manufacturer Country | DA |
| Manufacturer Postal Code | 2700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC PO2/PCO2 ELECTRODE |
| Generic Name | TC PO2/PCO2 ELECTRODE |
| Product Code | LKD |
| Date Received | 2019-01-10 |
| Model Number | 945-377 |
| Catalog Number | 945-377 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AAKANDEVEJ 21 BROENSHOEJ, 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-10 |