MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-13 for BROSELOW TAPE manufactured by Unk.
[92043668]
In a recent code white, there was a delay in determining which concentration of epinephrine to use for endotracheal administration because the broselow tape (from 2011) uses the ratio expression for dosing whereas the new labeling for epinephrine is in mg/ml. "does the new 2017 broselow tape state the epinephrine concentration to use as a ratio expression or in mg/ml. " if it does, it is a simple fix for us to buy new broselow tapes. If not, this is a major problem. (b)(4). Access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073329 |
| MDR Report Key | 7028341 |
| Date Received | 2017-11-13 |
| Date of Report | 2017-08-29 |
| 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 | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BROSELOW TAPE |
| Generic Name | MEASURING TAPE |
| Product Code | FTY |
| Date Received | 2017-11-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-13 |