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 2019-01-28 for TC ELECTRODE 945-605 manufactured by Radiometer Medical Aps.
[134178226]
Associated importer report - (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[134178227]
According to the complaint received, a patient sensor burn from a tcpo2 sensor used with a tcm400 monitor was reported. A (b)(6) year-old female patient being treated for chronic refractory osteomyelitis was subjected to in-chamber treatment on (b)(6) 2019, where a tcm400 monitor was applied. On (b)(6) 2019, the patient came back from hyperbaric oxygen treatment and a wound was identified on her leg in the area where the sensor was placed. The patient was admitted to the wound care center where the wound currently is being treated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002807968-2019-00002 |
| MDR Report Key | 8280617 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-28 |
| Date of Report | 2019-10-04 |
| Date of Event | 2019-01-03 |
| Date Mfgr Received | 2019-09-23 |
| Device Manufacturer Date | 2007-03-09 |
| Date Added to Maude | 2019-01-28 |
| 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 | MS. BOLETTE DUUN-CHRISTENSEN |
| 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 ELECTRODE |
| Generic Name | TC ELECTRODE |
| Product Code | LPP |
| Date Received | 2019-01-28 |
| Model Number | 945-605 |
| Catalog Number | 945-605 |
| Lot Number | TQ-01 027 |
| 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 | 2019-01-28 |