MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-29 for UNK * manufactured by Invacare Corporation.
[426087]
The patient involved is a homecare patient. The equipment involved was rented by the patient from an outside vendor. The patient was being helped into bed by a family member. The patient was using the bed trapeze. The bed trapeze broke and the patient fell down on the bed rail on the right hip. Homecare personnel contact facility, but the vendor declined to provide the model number or manufacturer of the trapeze.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 621655 |
| MDR Report Key | 621655 |
| Date Received | 2005-06-29 |
| Date of Report | 2005-06-29 |
| Date of Event | 2005-06-25 |
| Report Date | 2005-06-29 |
| Date Reported to FDA | 2005-06-29 |
| Date Added to Maude | 2005-07-20 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | BED TRAPEZE |
| Product Code | ILZ |
| Date Received | 2005-06-29 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 611302 |
| Manufacturer | INVACARE CORPORATION |
| Manufacturer Address | 1 INVACARE WAY ELYRIA OH 44035 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-06-29 |