MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-03-21 for HEEL RAISER, PROTECTOR MDT823296 manufactured by Medline Industries, Inc..
[18564038]
The facility reported that there were multiple reports of stage ii ulcers associated with the use of the heel protector. No other details were provided. We have no sample and no lot number. The facility did not respond to multiple requests asking for more information. We do not know how long the heel protectors were left in place and whether regular skin assessments had taken place. We do not know how many incidents occurred and if any medical intervention was indicated. We have not confirmed that the heel protectors caused or contributed to the incidents but in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[18569705]
The facility reported that patients developed stage ii decubitus ulcers while wearing the heel protectors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2014-00032 |
| MDR Report Key | 3698632 |
| Report Source | 05,06 |
| Date Received | 2014-03-21 |
| Date of Report | 2014-03-17 |
| Date Mfgr Received | 2014-02-18 |
| Date Added to Maude | 2014-03-26 |
| 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 | 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 | HEEL RAISER, PROTECTOR |
| Product Code | FMP |
| Date Received | 2014-03-21 |
| 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 | 2014-03-21 |