MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2001-03-29 for RAISED TOILET SEAT 1391 AP RAISED TOILET SE manufactured by Invacare Corporation.
[21711097]
Manufacturer received a report from a facility that the spouse of the consumer alleges patient was injured in a fall when their raised toilet seat disconnected from the toilet. What role, if any did invacare device caused or contributed to the incident, is unclear. The patient subsequently died of pneumonia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2001-00061 |
| MDR Report Key | 325483 |
| Report Source | 00 |
| Date Received | 2001-03-29 |
| Date of Report | 2001-03-26 |
| Date of Event | 2000-12-23 |
| Date Mfgr Received | 2001-03-19 |
| Date Added to Maude | 2001-04-11 |
| 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 | 2001-03-29 |
| Model Number | RAISED TOILET SEAT |
| Catalog Number | 1391 AP RAISED TOILET SE |
| 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 | 314938 |
| Manufacturer | INVACARE CORPORATION |
| Manufacturer Address | 899 CLEVELAND STREET 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 | 2001-03-29 |