MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-09-10 for SCALE-TRONIX 6006 * manufactured by Scale-tronix.
[17246682]
As pt stepped onto scale, the bottom plate tipped up on the opposite side causing the pt to lose balance and fall back. There appeared to be a problem with stability of the bottom plate. The pt sustained a 1" cut to back of head requiring staples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 415480 |
| MDR Report Key | 415480 |
| Date Received | 2002-09-10 |
| Date of Event | 2002-08-28 |
| Date Facility Aware | 2002-08-28 |
| Date Added to Maude | 2002-09-12 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | SCALE-TRONIX |
| Generic Name | WHEELCHAIR SCALE |
| Product Code | INF |
| Date Received | 2002-09-10 |
| Model Number | 6006 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 9 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 404518 |
| Manufacturer | SCALE-TRONIX |
| Manufacturer Address | PO BOX 15 WHEATON IL 60189 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-09-10 |