MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2012-07-18 for ESSENTIAL RAISED TOILET SEAT RPM67034 B5051 manufactured by Foshan R. Poon Medical Products Co., Ltd.
[21261624]
Dealer reports that this raised toilet seat unlocked while pt was sitting on it and pt became stuck between toilet and wall. Pt's daughter reported that seat wobbled after being installed by pt's son. Pt did not report injury at time of incident, however she was being treated for compression fractures of the spine and mri subsequent to the event shows an additional compression fracture above the previously injured area. Unit was returned and evaluated. No malfunction was found and the fit and function test proved that the unit, when properly installed, is secure and does not move.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2012-00011 |
| MDR Report Key | 2665038 |
| Report Source | 99 |
| Date Received | 2012-07-18 |
| Date of Report | 2012-07-18 |
| Date of Event | 2012-06-22 |
| Date Facility Aware | 2012-06-25 |
| Report Date | 2012-07-18 |
| Date Reported to FDA | 2012-07-18 |
| Date Reported to Mfgr | 2012-07-18 |
| Date Added to Maude | 2012-07-24 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESSENTIAL RAISED TOILET SEAT |
| Generic Name | RAISED TOILET SEAT |
| Product Code | INB |
| Date Received | 2012-07-18 |
| Model Number | RPM67034 |
| Catalog Number | B5051 |
| Device Availability | Y |
| Device Age | 10 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD |
| Manufacturer Address | NEW CITY DISTRICT, DONZAO, NANHAIM FOSHA 528216 CH 528216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-18 |