MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-02-19 for COMMODE RAISED TOILET SEAT manufactured by Invacare Corp..
[17907661]
Letter from a user reported that a toilet seat shifted when the pt attempted to get up. This allegedly caused her to fall and reinjure her back. Attempts to evaluate the device or otherwise gather more info have thus far been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-1997-00009 |
| MDR Report Key | 71010 |
| Report Source | 00 |
| Date Received | 1997-02-19 |
| Date of Report | 1997-02-11 |
| Date Mfgr Received | 1997-02-04 |
| Date Added to Maude | 1997-02-26 |
| 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 |
| 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 | COMMODE |
| Generic Name | DAILY ACTIVITY ASSIST DEVICE |
| Product Code | IKW |
| Date Received | 1997-02-19 |
| Model Number | RAISED TOILET SEAT |
| Catalog Number | RAISED TOILET SEAT |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 70916 |
| 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 | 1997-02-19 |