MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-19 for AMBU EEG LEADS manufactured by Ambu Sdn.bhd..
[137242681]
Following a hospitalization for a stroke, (b)(6) was admitted to university hospital in (b)(6)on jan 14th to the er. There she spent all day and night in the er and then on monday was placed on an eeg with the ambu leads. She was then transferred to an icu bed on tuesday late morning where she still had the eeg on. On wednesday when the decision was made by the family, present there to cease therapy and remove the leads and transfer her to a hospice bed, the tech and nurse present removed the leads and severe burns were noted to the shock of the nurse and tech. Pictures enclosed. These severe burns, according to the tech and nurse should not have happened and if it were not for the decision to remove the leads, the burns could have been even more severe and since the forehead has such little skin, it would have reached the bone. This adverse effect is not acceptable and should not have to happen to anyone else especially since the nurse said that the hospital switched to these recently and that they are also used in pediatric cases too. Since the patient was not responsive, there is no way to see if additional pain was inflicted due to the burning from these leads. A report was to be filed by the nurse to the hospital but that has not been confirmed at this time. I am also sending this report to the administration.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5084163 |
| MDR Report Key | 8358877 |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-12 |
| Date of Event | 2019-01-16 |
| Date Added to Maude | 2019-02-21 |
| 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 |
| 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 EEG LEADS |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2019-02-19 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AMBU SDN.BHD. |
| Manufacturer Address | 6230 OLD DOBBIN LN STE 250 COLUMBIA MD 21045 US 21045 |
| Brand Name | AMBU EEG LEADS |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2019-02-19 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMBU INC. |
| Manufacturer Address | 6230 OLD DOBBIN LN STE 250 COLUMBIA MD 21045 US 21045 |
| Brand Name | AMBU EEG LEADS |
| Generic Name | ELECTRODE, CUTANEOUS |
| Product Code | GXY |
| Date Received | 2019-02-19 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | AMBU INC. |
| Manufacturer Address | 6230 OLD DOBBIN LN STE 250 COLUMBIA MD 21045 US 21045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-19 |