MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-16 for HEELMEDIX MDT823330CS manufactured by Medline Industries, Inc..
[5649936]
While wearing the device, the patient developed a pressure ulcer on the calf of his right leg.
Patient Sequence No: 1, Text Type: D, B5
[13245480]
The facility reported that after wearing the heel protectors for two days, the boots were removed and a pressure ulcer was noted on his right calf. This patient had many co-morbidities and had been hospitalized for over a year with multiple complications. The contact at the facility indicated that skin assessments were done routinely, however the pressure ulcer became unstageable. It is unk if the device was appropriately sized or applied correctly. The facility reported the pressure ulcer was primarily related to the patient's condition and co-morbidities. They had no information to suggest the device caused the tissue injury but reported it in an abundance of caution. No sample was returned for evaluation. No lot number was provided.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2015-00034 |
| MDR Report Key | 4713230 |
| Report Source | 06 |
| Date Received | 2015-04-16 |
| Date of Report | 2015-04-14 |
| Date of Event | 2014-10-29 |
| Date Mfgr Received | 2015-03-18 |
| Date Added to Maude | 2015-04-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEELMEDIX |
| Product Code | FMP |
| Date Received | 2015-04-16 |
| Catalog Number | MDT823330CS |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-16 |