MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-08 for "TRAINOR" GEL ANKLE STIRRUP manufactured by Brown Med Industry.
[18078]
Pt was provided with an "trainor" gill ankle stirrup splint on 2/13/95 after her short leg cast was removed s/p fracture. Pt ambulated with pt and wore splint without problems until session on 2/21/95. Pt checked skin integrity as part of normal rx. Pt found that the gel pads around both malleoli on right ankle had solidified and cracked, causing increased pressure over these boney prominences. Skin breakdown was noted over medical malleolus and redness from increased pressure noted over lateral malleolus. Pt removed splint, reported incident to don, adon, administrator, and orthopedist. Pt returned splint to orthopedist to show as evidence to the sales rep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 28373 |
| MDR Report Key | 28373 |
| Date Received | 1995-03-08 |
| Date of Report | 1995-02-24 |
| Date of Event | 1995-02-21 |
| Date Added to Maude | 1995-12-05 |
| 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 | PHYSICAL THERAPIST |
| 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 | "TRAINOR" GEL ANKLE STIRRUP |
| Generic Name | STIRRUP ANKLE SPLINT |
| Product Code | FYH |
| Date Received | 1995-03-08 |
| Returned To Mfg | 1995-02-22 |
| Operator | OTHER |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 29301 |
| Manufacturer | BROWN MED INDUSTRY |
| Manufacturer Address | HARTLEY IA 51346 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-03-08 |