MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-15 for ORTHO GLASS * 0G-3L manufactured by Parker Medical Associates.
[17103865]
Orhto splint applied for wrist fracture. Pt suffered skin trauma, was seen at another emergency room, skin breakdown was observed on pt's arm by physician checking under splint. Splint was on for only 2 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 91591 |
| MDR Report Key | 91591 |
| Date Received | 1995-02-15 |
| Date of Report | 1994-11-18 |
| Date of Event | 1994-10-28 |
| Date Facility Aware | 1994-11-15 |
| Report Date | 1994-11-18 |
| Date Added to Maude | 1997-05-20 |
| 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 | ORTHO GLASS |
| Generic Name | FIBERGLASS SPLINT SYSTEM |
| Product Code | FYH |
| Date Received | 1995-02-15 |
| Model Number | * |
| Catalog Number | 0G-3L |
| Lot Number | G43108 POSSIBLE LOT# |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 90477 |
| Manufacturer | PARKER MEDICAL ASSOCIATES |
| Manufacturer Address | 2401 DISTRIBUTION ST CHARLOTTE NC 28203 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-02-15 |