MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for TC ELECTRODE 945-605 manufactured by Radiometer Medical Aps.
[134186747]
Associated manufacturers report - 3002807968-2019-00002.
Patient Sequence No: 1, Text Type: N, H10
[134186748]
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 | 1523456-2019-00001 |
| MDR Report Key | 8280937 |
| Date Received | 2019-01-28 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-01-03 |
| Date Facility Aware | 2019-01-07 |
| Report Date | 2019-01-25 |
| Date Reported to FDA | 2019-01-25 |
| Date Reported to Mfgr | 2019-01-08 |
| Date Added to Maude | 2019-01-28 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| 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 | 11 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | AAKANDEVEJ 21 BROENSHOEJ, DA 2700 DA 2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-28 |