MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-10 for ART OF CARE RECLINER manufactured by Hill-rom.
[44793007]
Patient Sequence No: 1, Text Type: N, H10
[44793008]
Rn answered patient call light. Patient was found with right lower leg caught in recliner chair. The recliner was opened and indentations, bruising, and a slight abrasion was noted to right shin area. Patient was assessed by primary nurse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5642879 |
| MDR Report Key | 5642879 |
| Date Received | 2016-05-10 |
| Date of Report | 2016-04-25 |
| Date of Event | 2016-01-25 |
| Report Date | 2016-04-25 |
| Date Reported to FDA | 2016-04-25 |
| Date Reported to Mfgr | 2016-04-25 |
| Date Added to Maude | 2016-05-10 |
| 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 | ART OF CARE RECLINER |
| Generic Name | CHAIR AND TABLE, MEDICAL |
| Product Code | KMN |
| Date Received | 2016-05-10 |
| ID Number | SP 13598350 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HILL-ROM |
| Manufacturer Address | 1069 STATE ROUTE 46 EAST J34 BATESVILLE IN 47006 US 47006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-10 |