MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-03 for MIDLAND 4512E UNK manufactured by Midland Mfg Inc..
[17170798]
Seventy two (72) year old pt who was admitted for left total hip and had subsequent complications including cva, had her nail on right great toe partially torn away. This was noted by both physical/occupational therapist after her treatment with the use of the standing frame.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1011624 |
| MDR Report Key | 102954 |
| Date Received | 1997-07-03 |
| Date of Report | 1997-06-15 |
| Date of Event | 1997-06-10 |
| Date Added to Maude | 1997-07-08 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDLAND |
| Generic Name | STANDING FRAME |
| Product Code | IPL |
| Date Received | 1997-07-03 |
| Model Number | 4512E |
| Catalog Number | UNK |
| Lot Number | CE- 30076 |
| ID Number | VOLTS 115, AMPS 3.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 101318 |
| Manufacturer | MIDLAND MFG INC. |
| Manufacturer Address | 802 UNIVERSAL DR. COLUMBIA SC 29209 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-07-03 |