MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-22 for MULTIPODUS BOOT 537257 manufactured by Unk..
[19799853]
Pressure area from shear/friction of multipodus/contracture boot. The problem may have been improperly fastened/ placed on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5040437 |
| MDR Report Key | 4465999 |
| Date Received | 2015-01-22 |
| Date of Report | 2015-01-22 |
| Date of Event | 2015-01-12 |
| Date Added to Maude | 2015-01-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MULTIPODUS BOOT |
| Generic Name | CONTRACTURE BOOT |
| Product Code | ITW |
| Date Received | 2015-01-22 |
| Model Number | 537257 |
| Catalog Number | 537257 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK. |
| Manufacturer Address | UNK UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-22 |