MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-25 for HEELMEDIX MDT823330CS manufactured by Medline Industries, Inc..
[20020049]
We were trialing these new off-loading devices for an alternative to multi-purpose foot boots who just need offloading of heels. I am not sure the day they replaced the boots, but the staff notes areas of irritation on the heel and contacted the company representative. The heelmedix devices were removed at that point but the patient developed pressure ulcers on his right calf that became un-stageable pressure ulcers. We reported this as a sentinel event and performed a root cause analysis. These heelmedix devices have been implemented in our facility. We feel that these ulcers were primarily related to the patient's condition but felt it should be reported in case this is a common trend, such as obese or diabetic patients, in which case an alternative method should be used for off-loading.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4584932 |
| MDR Report Key | 4584932 |
| Date Received | 2015-02-25 |
| Date of Report | 2015-02-24 |
| Date of Event | 2014-10-29 |
| Report Date | 2015-02-24 |
| Date Reported to FDA | 2015-02-25 |
| Date Reported to Mfgr | 2015-03-10 |
| Date Added to Maude | 2015-03-10 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEELMEDIX |
| Generic Name | PROTECTOR, SKIN PRESSURE |
| Product Code | FMP |
| Date Received | 2015-02-25 |
| Model Number | MDT823330CS |
| Catalog Number | MDT823330CS |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2015-02-25 |