MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2013-06-21 for WHEELCHAIR ACCESSORY R111 manufactured by New Prokin.
[3466768]
Resident was being lift from her wheelchair when the sling ripped and the user fell.
Patient Sequence No: 1, Text Type: D, B5
[10745570]
(b)(4). The user fell on her right side of her rib cage and sustained bruising. Medical intervention was required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1531186-2013-02733 |
| MDR Report Key | 3181907 |
| Report Source | * |
| Date Received | 2013-06-21 |
| Date of Report | 2013-05-23 |
| Date Facility Aware | 2013-05-23 |
| Report Date | 2013-06-20 |
| Date Reported to FDA | 2013-06-20 |
| Date Reported to Mfgr | 2013-06-20 |
| Date Added to Maude | 2013-06-21 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHEELCHAIR ACCESSORY |
| Generic Name | 890.3910 |
| Product Code | INE |
| Date Received | 2013-06-21 |
| Model Number | R111 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEW PROKIN |
| Manufacturer Address | ZHONGSHAN CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2013-06-21 |