MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2013-03-22 for WHEELCHAIR ACCESSORY R100P manufactured by New Prokin.
[3258546]
(b)(4). No serious injury alleged. Malfunction alleged. Representative from facility alleged that the sling ripped. She said patient is (b)(6). Mdr filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2013-01221 |
| MDR Report Key | 3018439 |
| Report Source | * |
| Date Received | 2013-03-22 |
| Date of Report | 2013-02-25 |
| Date Facility Aware | 2013-02-25 |
| Report Date | 2013-03-22 |
| Date Reported to FDA | 2013-03-22 |
| Date Reported to Mfgr | 2013-03-22 |
| Date Added to Maude | 2013-03-22 |
| 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 | 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 | 2013-03-22 |
| Model Number | R100P |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2013-03-22 |