MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-21 for PROCAIR PLUS MATTRESS 222-3684 manufactured by Fxi.
[180530501]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[180530502]
It was reported to the manufacturer by the end user, per the end user, caretaker changing sheets while patient was on equipment and during the process patient moved to the side to quickly and fell off the equipment. The patient was taken to the hospital and sustained injuries to the right side of the body. Complaint# (b)(4) was entered into our system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009402404-2020-00017 |
| MDR Report Key | 9741204 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-30 |
| Date Mfgr Received | 2020-02-21 |
| Date Added to Maude | 2020-02-21 |
| 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 | FELICIA BANKS |
| Manufacturer Street | 2100 DESIGN ROAD |
| Manufacturer City | ARLINGTON, TX |
| Manufacturer Country | US |
| Manufacturer Phone | 8260270331 |
| Manufacturer G1 | FXI |
| Manufacturer Street | 1032 N 4TH ST. |
| Manufacturer City | BALDWYN, MS |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCAIR PLUS MATTRESS |
| Generic Name | PATIENT AIR MATTRESS |
| Product Code | FNM |
| Date Received | 2020-02-21 |
| Model Number | 222-3684 |
| Catalog Number | 222-3684 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FXI |
| Manufacturer Address | 1032 N 4TH ST. BALDWYN, MS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-21 |