MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-28 for RESTING PAN SPLINT manufactured by Unknown.
[15901]
Upon removal of resting pan splint from left hand a 1 1/2 cm pressure area/laceration noted on base of left thumb from edge of splint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22060 |
| MDR Report Key | 22060 |
| Date Received | 1995-04-28 |
| Date of Report | 1995-04-28 |
| Date of Event | 1995-04-24 |
| Date Facility Aware | 1995-04-24 |
| Date Added to Maude | 1995-06-01 |
| 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 | RESTING PAN SPLINT |
| Generic Name | RESTING PAN SPLINT |
| Product Code | ILH |
| Date Received | 1995-04-28 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 22149 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-04-28 |