MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-04-15 for 2007-A BROSELOW TAPE #AE4800 manufactured by Ge.
[21284992]
This report did not effect any pt care outcome but is a concern to our facility. The manufacturer of the broselow tape suggested to black out the kg/does on the glucagon calculation basis section of the tape. We received a letter from a dr explaining this. We feel this to be a huge safety concern and would like the fda view of this. I have seen no recalls in respect to this. Dates of use: estimate, 2007 - 2009. Diagnosis or reason for use: for pediatric codes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5010785 |
| MDR Report Key | 1365313 |
| Date Received | 2009-04-15 |
| Date of Report | 2009-04-15 |
| Date of Event | 2009-03-02 |
| Date Added to Maude | 2009-05-06 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2007-A BROSELOW TAPE |
| Generic Name | NA |
| Product Code | FTY |
| Date Received | 2009-04-15 |
| Model Number | #AE4800 |
| Lot Number | PRODUCT# AE4800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-15 |