MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 1999-06-11 for RAISED TOILET SEAT 1391 RAISED TOILET SEAT manufactured by Invacare Corp.
[126894]
Mfr received a report from an attorney alleging that a raised toilet seat slid off a commode, causing a pt to slip and fall. The installation, assembly and operating instructions that are shipped with this device warn that the seat may not work on designer toilet bowls and must be checked for proper fit and assembly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-1999-00052 |
| MDR Report Key | 227185 |
| Report Source | 04 |
| Date Received | 1999-06-11 |
| Date of Report | 1999-06-10 |
| Date of Event | 1997-11-01 |
| Date Mfgr Received | 1999-05-10 |
| Date Added to Maude | 1999-06-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAISED TOILET SEAT |
| Generic Name | DAILY ACTIVITY ASSIST DEVICE |
| Product Code | IKW |
| Date Received | 1999-06-11 |
| Model Number | RAISED TOILET SEAT |
| Catalog Number | 1391 RAISED TOILET SEAT |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 220290 |
| Manufacturer | INVACARE CORP |
| Manufacturer Address | 899 CLEVELAND ST ELYRIA OH 44035 US |
| Baseline Brand Name | COMMODE |
| Baseline Generic Name | DAILY ACTIVITY ASSIST DEVICE |
| Baseline Model No | RAISED TOILET S |
| Baseline Catalog No | RAISED TOILET SEAT |
| Baseline ID | NA |
| Baseline Device Family | DAILY ACTIVITY ASSIST DEVICE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-06-11 |