MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-15 for 300 WOUND SURFACE manufactured by Hill-rom, Inc..
[94956837]
Patient Sequence No: 1, Text Type: N, H10
[94956838]
The visitor tripped on the air mattress hose at the right foot of patient's bed. Loud noise was heard and then a cry for help. The visitor found on her hands and knees. Bleeding from bridge of nose and left hand. Pain in left prosthetic knee and right shoulder with arm movement. Patient hit her face on patient's wheelchair when she tripped. Band aid applied to bridge of nose and 2 areas on left hand with abrasions as she was bleeding. Assisted into wheelchair by nursing staff and transported to ed for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7120443 |
| MDR Report Key | 7120443 |
| Date Received | 2017-12-15 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-12-09 |
| Report Date | 2017-12-14 |
| Date Reported to FDA | 2017-12-14 |
| Date Reported to Mfgr | 2017-12-14 |
| Date Added to Maude | 2017-12-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 300 WOUND SURFACE |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2017-12-15 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM, INC. |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-15 |