MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for DIRECT SUPPLY FOLDING SHOWER BED FSG350 manufactured by Innovative Products Unlimited, Inc..
[121895729]
On (b)(6) 2018, patient was placed on gurney for shower. The pin holding the leg of the top portion popped out, resulting in patient falling to floor. Diagnosed with scalp hematoma and wedge compression fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080118 |
| MDR Report Key | 7910358 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-11 |
| Date of Event | 2018-07-16 |
| Date Added to Maude | 2018-09-26 |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIRECT SUPPLY FOLDING SHOWER BED |
| Generic Name | CHAIR, ADJUSTABLE MECHANICAL |
| Product Code | INN |
| Date Received | 2018-09-25 |
| Model Number | FSG350 |
| 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 | 2018-09-25 |