MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-04-24 for INVACARE TRACTION ACCESSORIES 7714 * manufactured by Invacare Corp.-manufacturing Facility.
[309351]
The letter from the attorney alleges that trapeze was installed on the side of the bed rather than the head of the bed and that as their feet were touching the floor, they tripped and stumbled over the base of the floor stand. The consumer alleges serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2004-00039 |
| MDR Report Key | 521804 |
| Report Source | 00 |
| Date Received | 2004-04-24 |
| Date of Report | 2004-04-16 |
| Date of Event | 2002-05-26 |
| Date Mfgr Received | 2004-04-08 |
| Date Added to Maude | 2004-04-26 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | RON CLINES |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 4403263115 |
| Manufacturer G1 | INVACARE CORPORATION |
| Manufacturer Street | 1200 TAYLOR ST |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVACARE TRACTION ACCESSORIES |
| Generic Name | 890.5920 |
| Product Code | ILZ |
| Date Received | 2004-04-24 |
| Model Number | 7714 |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 510931 |
| Manufacturer | INVACARE CORP.-MANUFACTURING FACILITY |
| Manufacturer Address | 1200 TAYLOR ST. ELYRIA OH 44036 US |
| Baseline Brand Name | INVACARE TRACTION ACCESSORIES |
| Baseline Generic Name | 890. 5920 |
| Baseline Model No | 7714 |
| Baseline Catalog No | * |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-04-24 |