MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-09 for HEEL RAISER ULTRA HEEL PROTECTOR MDT82705CS manufactured by Medline Industries Inc.
[74725782]
Patient Sequence No: 1, Text Type: N, H10
[74725783]
Heel protector boot actually caused a small deep tissue injury to patient's right lateral foot. This occurred a couple of months ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6553624 |
| MDR Report Key | 6553624 |
| Date Received | 2017-05-09 |
| Date of Report | 2017-05-01 |
| Date of Event | 2017-02-16 |
| Report Date | 2017-04-04 |
| Date Reported to FDA | 2017-04-04 |
| Date Reported to Mfgr | 2017-04-04 |
| Date Added to Maude | 2017-05-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Brand Name | HEEL RAISER ULTRA HEEL PROTECTOR |
| Generic Name | PROTECTOR, SKIN PRESSURE |
| Product Code | FMP |
| Date Received | 2017-05-09 |
| Model Number | MDT82705CS |
| Catalog Number | MDT82705CS |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-09 |