MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-10 for PREMIUM HEEL GUARD 6145 manufactured by J. T. Posey Co..
[5447112]
Customer reported the pt had heel blister and a small deep tissue injury (dti).
Patient Sequence No: 1, Text Type: D, B5
[13013855]
Product was requested to be returned for eval and has not been received. This submission is based solely on the user facility's reported issue. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2015-00031 |
| MDR Report Key | 4589049 |
| Report Source | 06 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-02 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-02-02 |
| Date Added to Maude | 2015-03-12 |
| 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 | SOKEA PEOU |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIUM HEEL GUARD |
| Product Code | FMP |
| Date Received | 2015-03-10 |
| Model Number | 6145 |
| Catalog Number | 6145 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Other | 2015-03-10 |