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..
[5479663]
Customer reported the pt had a bilateral breakdown on the outside of the foot and a small deep tissue injury (dti).
Patient Sequence No: 1, Text Type: D, B5
[5656097]
Supplemental based on no product return evaluation.
Patient Sequence No: 1, Text Type: D, B5
[13051862]
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
[13109081]
Conclusions: without the return of the product and/or images provided, the complaint could not be confirmed. Per report, the hospital checks once every shift at minimum, which does not meet the ifu specified to check at least every two hours. It is possible that this caused the reported bilateral breakdown on the outside of the foot and small deep tissue issue. Note: all complaints are trended and reviewed by management on a monthly basis. As a part of the monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. No corrective or preventative actions are necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020362-2015-00033 |
| MDR Report Key | 4589027 |
| Report Source | 06 |
| Date Received | 2015-03-10 |
| Date of Report | 2015-03-19 |
| Date of Event | 2015-01-01 |
| Date Mfgr Received | 2015-03-19 |
| 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 | 0 |
| 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 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PREMIUM HEEL GUARD |
| Generic Name | PROTECTOR, SKIN PRESSURE |
| 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 | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 |