MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-30 for RAZ REHAB SHOWER CHAIR (HCPCS #E0240) SP manufactured by Raz Design Inc..
[177549756]
While (b)(6) was showering using the shower chair on (b)(6) 2017, the seat completely gave way, collapsing and causing one of the stainless steel rods that support the seat to impale his anus and colon. His colon was perforated in six different places. This wire removed the rod from his rectum before emergency responders arrived.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092673 |
| MDR Report Key | 9654285 |
| Date Received | 2020-01-30 |
| Date of Report | 2020-01-22 |
| Date of Event | 2017-03-20 |
| Date Added to Maude | 2020-01-31 |
| 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 | ATTORNEY |
| 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 | 3 |
| Brand Name | RAZ REHAB SHOWER CHAIR (HCPCS #E0240) |
| Generic Name | CHAIR, ADJUSTABLE MECHANICAL |
| Product Code | INN |
| Date Received | 2020-01-30 |
| Model Number | SP |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RAZ DESIGN INC. |
| Manufacturer Address | TORONTO, ON CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Deathisabilit | 2020-01-30 |