MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2014-08-13 for TRANSCUTANEOUS BLOOD GAS MONITOR TCM4 SERIES 391-880 manufactured by Radiometer Medical Aps,.
[5117036]
According to the complaint, a (b)(4) year old child received a small abrasion/skin reaction or burn on the arm after using the tcm4 for a sleep study. After a week it was still not healed. More info, including a picture of the injury, has been requested in order to further specify the type of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523456-2014-00004 |
| MDR Report Key | 4376022 |
| Report Source | 99 |
| Date Received | 2014-08-13 |
| Date of Report | 2014-07-14 |
| Date of Event | 2014-07-03 |
| Date Facility Aware | 2014-07-14 |
| Report Date | 2014-07-14 |
| Date Reported to FDA | 2014-08-13 |
| Date Reported to Mfgr | 2014-08-13 |
| Date Added to Maude | 2015-01-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 810 SHARON DR. |
| Manufacturer City | WESTLAKE OH 441451598 |
| Manufacturer Country | US |
| Manufacturer Postal | 441451598 |
| Manufacturer G1 | RADIOMETER AMERICA, INC. |
| Manufacturer Street | 810 SHARON DR. |
| Manufacturer City | WESTLAKE OH 44145159 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44145 1598 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCUTANEOUS BLOOD GAS MONITOR |
| Generic Name | TCM4 MONITORING SYSTEM |
| Product Code | LKD |
| Date Received | 2014-08-13 |
| Model Number | TCM4 SERIES |
| Catalog Number | 391-880 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS, |
| Manufacturer Address | AKANDEVEJ 21 BRONSHOJ DK-2700 DA DK-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-13 |