MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-29 for CANE/SLING SEAT SST6856 manufactured by Ample Source Trading Company.
[5266712]
A customer was in her elevator sitting on her cane sling seat and the seam broke on one of the sides of the seat, causing her to fall to the ground. Dates of use: (b)(6) 2014. Diagnosis or reason for use: used as a mobility aid and chair for rest.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039885 |
| MDR Report Key | 4379892 |
| Date Received | 2014-12-29 |
| Date of Report | 2014-12-29 |
| Date of Event | 2014-12-14 |
| Date Added to Maude | 2015-01-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CANE/SLING SEAT |
| Generic Name | CANE/SLING SEAT |
| Product Code | KHY |
| Date Received | 2014-12-29 |
| Model Number | SST6856 |
| ID Number | 017874010882 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMPLE SOURCE TRADING COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-29 |