MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-07-18 for AMBU BALTROPBAKKEN 13 72615-M/10 manufactured by Ambu Inc..
[50246013]
Seizure pt undergoing eeg monitoring fell and hit head. Eeg electrodes shattered into pieces with sharp edges and punctured pt's skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063534 |
| MDR Report Key | 5811655 |
| Date Received | 2016-07-18 |
| Date of Report | 2016-07-18 |
| Date of Event | 2016-07-01 |
| Date Added to Maude | 2016-07-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | ATTORNEY |
| 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 | AMBU |
| Generic Name | AMBU NEUROLINE SINGLE PT CUP |
| Product Code | GXZ |
| Date Received | 2016-07-18 |
| Model Number | BALTROPBAKKEN 13 |
| Catalog Number | 72615-M/10 |
| Lot Number | 1878700 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU INC. |
| Manufacturer Address | COLUMBIA MD 21045 US 21045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-18 |