MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-19 for MEDLINE HEELMEDIX BOOTS manufactured by Medline Industries, Inc..
[106300292]
Patient wearing bilateral medline heelmedix boots to offload bilateral heels. The patient's heels were not being offloaded by the boot when inspected. The feet had slipped back and the heels were lying on the back part of the boots. Upon inspection of the right medial heel, a deep purple discoloration was discovered indicating a possible deep tissue injury. This was not discovered on admission but within 24 hours of admission, it is believed to likely have been caused by the boot not fitting properly despite being applied per instructions.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076632 |
| MDR Report Key | 7450493 |
| Date Received | 2018-04-19 |
| Date of Report | 2018-04-10 |
| Date of Event | 2018-03-20 |
| Date Added to Maude | 2018-04-23 |
| 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 | RISK MANAGER |
| 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 | MEDLINE HEELMEDIX BOOTS |
| Generic Name | PROTECTOR, SKIN PRESSURE |
| Product Code | FMP |
| Date Received | 2018-04-19 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-19 |