MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-05 for SHOWER BUDDY manufactured by Showerbuddy Global Ltd..
[88447906]
Showerbuddy chair equipment failure, client fell out of chair and sustained minor scratches to his back.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW5072611 |
MDR Report Key | 6916077 |
Date Received | 2017-10-05 |
Date of Report | 2017-10-03 |
Date of Event | 2017-10-03 |
Date Added to Maude | 2017-10-05 |
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 |
Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
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 | 0 |
Brand Name | SHOWER BUDDY |
Generic Name | DEVICE, TRANSFER, PATIENT |
Product Code | FMR |
Date Received | 2017-10-05 |
Device Availability | Y |
Device Eval'ed by Mfgr | I |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SHOWERBUDDY GLOBAL LTD. |
Manufacturer Address | NZ |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2017-10-05 |