MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-07-18 for PROTECTOR, HEEL RAISER MDT823296 manufactured by Medline Industries, Inc..
[20755898]
While wearing the device, the pt developed deep tissue injuries of the heel.
Patient Sequence No: 1, Text Type: D, B5
[20875980]
The pt developed a deep tissue injury to both heels after wearing the boots for 90 days. The left measured 1. 5 cm x 2 cm and the right measured 2 cm x 3 cm. The facility reported that skin assessments were performed every shift. Dressings were applied and off loading boots were initiated. No sample was returned for eval. No lot number was provided. A root cause has not been determined. We have not confirmed the device caused or contributed to the reported tissue injury.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00071 |
| MDR Report Key | 3964905 |
| Report Source | 06 |
| Date Received | 2014-07-18 |
| Date of Event | 2014-05-14 |
| Date Mfgr Received | 2014-06-19 |
| Date Added to Maude | 2014-07-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | PROTECTOR, HEEL RAISER |
| Product Code | FMP |
| Date Received | 2014-07-18 |
| Catalog Number | MDT823296 |
| 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 | 2014-07-18 |