MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-02-26 for TCM TCM4 391-878 manufactured by Radiometer Medical Aps.
[1423010]
On (b)(6) 2010, an e-mail was sent to a local sales representative reporting the following: during a sleep study, the patient was monitored using a transcutaneous monitoring device and suffered a burn to the upper chest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1523456-2010-00002 |
| MDR Report Key | 1621607 |
| Report Source | 99 |
| Date Received | 2010-02-26 |
| Date of Report | 2010-02-03 |
| Date of Event | 2009-08-24 |
| Date Facility Aware | 2010-02-03 |
| Report Date | 2010-02-17 |
| Date Reported to FDA | 2010-02-26 |
| Date Reported to Mfgr | 2010-02-08 |
| Date Added to Maude | 2010-10-15 |
| 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TCM |
| Generic Name | TCM4 |
| Product Code | KLK |
| Date Received | 2010-02-26 |
| Returned To Mfg | 2010-02-12 |
| Model Number | TCM4 |
| Catalog Number | 391-878 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RADIOMETER MEDICAL APS |
| Manufacturer Address | BROENSHOEJ (COPENHAGEN) KD-2700 DA KD-2700 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-02-26 |