MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-06 for PAD SET WILSON FRAME TEMPUR PEDIC 5319-37 manufactured by Mizuho Orthopedic Systems, Inc..
[183890177]
It was reported the pad on the right side seems to have to much flexible give on the inside. When they lay the patient down on top of the frame the pad slides outwards causing the plastic frame beneath the pad to be exposed and cause pressure red marks on their patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2921578-2020-00012 |
| MDR Report Key | 9799225 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-06 |
| Date of Report | 2020-03-06 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Date Added to Maude | 2020-03-06 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE LEBLANC |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4291500233 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVENUE |
| Manufacturer City | UNION CITY, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAD SET WILSON FRAME TEMPUR PEDIC |
| Generic Name | PAD |
| Product Code | JEA |
| Date Received | 2020-03-06 |
| Model Number | 5319-37 |
| Catalog Number | 5319-37 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Address | 30031 AHERN AVENUE UNION CITY, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-06 |