MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2013-04-03 for NON AC-POWERED PATIENT LIFT R101 manufactured by New Prokin.
[3200875]
The user reported that the sling used on their patient lift had worn straps that were tearing. This issue could cause the sling to be unstable and the user to fall out of the sling during use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2013-01391 |
| MDR Report Key | 3033927 |
| Report Source | * |
| Date Received | 2013-04-03 |
| Date of Report | 2013-03-07 |
| Date Facility Aware | 2013-03-07 |
| Report Date | 2013-04-03 |
| Date Reported to FDA | 2013-04-03 |
| Date Reported to Mfgr | 2013-04-03 |
| Date Added to Maude | 2013-04-03 |
| 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 | PATIENT |
| 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 | NON AC-POWERED PATIENT LIFT |
| Generic Name | 880.5510 |
| Product Code | INE |
| Date Received | 2013-04-03 |
| Model Number | R101 |
| 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. Other | 2013-04-03 |