MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for EEG LEAD manufactured by Unk.
[92024748]
Mri performed on patient with mri condition eeg leads. Mri unsafe lead/wire, identical in gauge, wound in with mri conditional leads and attached to patient chest causing a burn on patient chest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073326 |
| MDR Report Key | 7027798 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-11-08 |
| Date Added to Maude | 2017-11-14 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EEG LEAD |
| Generic Name | EEG LEAD |
| Product Code | IKD |
| Date Received | 2017-11-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-13 |