MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-12 for PRO-HEELX HEEL PROTECTOR 6218S manufactured by J. T. Posey Co..
[4628965]
Customer reported while her mother was in use with the heel protector for her decubitis ulcer on her heel, her skin under her toes turned black. Customer confirmed that the proheelix was not removed every two hours according to the ifu. The date when the issue was discovered was not provided.
Patient Sequence No: 1, Text Type: D, B5
[12149424]
Product was requested to be returned for evaluation and has not been received. Note: this report is being submitted solely on the customer's reported issue. Manufacturer (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2014-00216 |
| MDR Report Key | 3953493 |
| Report Source | 06 |
| Date Received | 2014-06-12 |
| Date of Report | 2014-05-12 |
| Date Mfgr Received | 2014-05-12 |
| Date Added to Maude | 2014-07-31 |
| 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 | ROXANA KOUSSA |
| Manufacturer Street | 5635 PECK RD. |
| Manufacturer City | ARCADIA CA 91006 |
| Manufacturer Country | US |
| Manufacturer Postal | 91006 |
| Manufacturer Phone | 6264433143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO-HEELX HEEL PROTECTOR |
| Product Code | FMP |
| Date Received | 2014-06-12 |
| Model Number | 6218S |
| Catalog Number | 6218S |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. T. POSEY CO. |
| Manufacturer Address | ARCADIA CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-12 |