MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-03-20 for RAISED TOILET SEAT 1391-A RAISED TOILET SEA manufactured by Invacare Corp..
[18450078]
Mfr received a report from a dealer that the enduser was leaning heavily on the seat when the clamps allegedly came loose, causing the user to fall and break their right hip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2001-00047 |
| MDR Report Key | 322208 |
| Report Source | 08 |
| Date Received | 2001-03-20 |
| Date of Report | 2001-03-12 |
| Date Mfgr Received | 2001-03-02 |
| Date Added to Maude | 2001-03-27 |
| 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 | 0 |
| Manufacturer Contact | RONALD CLINES |
| Manufacturer Street | ONE INVACARE WAY. |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 4403263115 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 2001-03-20 |
| Model Number | RAISED TOILET SEAT |
| Catalog Number | 1391-A RAISED TOILET SEA |
| 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 | 311699 |
| 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 | 2001-03-20 |