MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-05 for SHOWER CHAIR COMMODE SCC9250 manufactured by Innovative Products Unlimited Inc..
[126366722]
Resident was receiving a shower with assistance and was sitting in the shower chair. The shower chair broke causing him to fall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081052 |
| MDR Report Key | 8041927 |
| Date Received | 2018-11-05 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-29 |
| Date Added to Maude | 2018-11-06 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 CHAIR COMMODE |
| Generic Name | CHAIR ADJUSTABLE, MECHANICAL |
| Product Code | INN |
| Date Received | 2018-11-05 |
| Model Number | SCC9250 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INNOVATIVE PRODUCTS UNLIMITED INC. |
| Manufacturer Address | NILES MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-11-05 |