MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-28 for VASCULAR BAND RADIAL COMPRESSION manufactured by Vascular Solutions Llc.
[122305963]
Vascular band did not initially inflate for about 5 seconds. Vascular band did inflate and hemostasis was achieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080207 |
| MDR Report Key | 7922280 |
| Date Received | 2018-09-28 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-26 |
| Date Added to Maude | 2018-10-01 |
| 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 | VASCULAR BAND RADIAL COMPRESSION |
| Generic Name | DRESSING, COMPRESSION |
| Product Code | MHW |
| Date Received | 2018-09-28 |
| Lot Number | 201804012 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VASCULAR SOLUTIONS LLC |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-28 |