D
Patient 1
CUSTOMER REPORTED THE PATIENT HAD A SKIN BREAKDOWN AND A SMALL DTI (DEEP TISSUE INJURY) AREA.
MAUDE MDR 4573838
- MDR report key
- 4573838
- Report number
- 2020362-2015-00035
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-01-01
- Date received
- 2015-03-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- WILLIAM HINCY
- Address
- POSEY COMPANY 5635 PECK ROAD ARCADIA CA 91006 US
- Phone
- 626-626-6264
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PREMIUM HEEL GUARD | PROTECTOR, SKIN PRESSURE | J.T. POSEY COMPANY | FMP | 6145 | 6145 | ASKU | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-03-05 | 0 | 1. O |
Event Narratives#
D
Patient 1
SUPPLEMENTAL SUBMISSION BASED ON NO PRODUCT RETURN EVALUATION.
N
Patient 1
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 ADDITIONAL OCCURRENCE WITH NO DETAILS. 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.
N
Patient 1
PRODUCT WAS REQUESTED TO BE RETURNED TO EVALUATION AND HAS NOT BEEN RECEIVED. NOTE: THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY'S REPORTED ISSUE. NOTE: POSEY INSTRUCTIONS FOR USE WARNS THE USER TO, "BE SURE TO FOLLOW YOUR FACILITY?S POLICIES AND GUIDELINES FOR FREQUENCY OF PATIENT MONITORING. INSPECT THE PATIENT?S LEG AT LEAST EVERY TWO HOURS TO CHECK FOR SKIN INTEGRITY, BLOOD CIRCULATION AND ADEQUATE ALLOWANCE FOR MOVEMENT OF LOWER LEG AND FOOT. INSPECT PRODUCTS BEFORE EACH USE: CHECK FOR BROKEN STITCHES; OR TORN, CUT OR FRAYED MATERIAL. DO NOT USE SOILED OR DAMAGED PRODUCTS. (B)(4).