MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-19 for OCL SPLINT ROLL UNKNOWN manufactured by Orthopedic Casting Lab, Inc..
[20897189]
Pt presented to the emergency dept with sprained right ankle. A cast was applied 5/17/92. Pt returned 5/18/92 with a 2 degree burn to lower back of right leg. Pt complained of "burns to leg because cast was too hot". This comment was made at time of return visit to the emergency dept.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17381 |
| MDR Report Key | 17381 |
| Date Received | 1994-09-19 |
| Date of Report | 1994-08-30 |
| Date of Event | 1992-05-17 |
| Date Facility Aware | 1992-05-20 |
| Report Date | 1994-08-30 |
| Date Added to Maude | 1994-11-03 |
| 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 | OCL SPLINT ROLL |
| Generic Name | SPLINT/CASTING MATERIAL |
| Product Code | LGF |
| Date Received | 1994-09-19 |
| Model Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17310 |
| Manufacturer | ORTHOPEDIC CASTING LAB, INC. |
| Manufacturer Address | EUDORA KS 66025 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-09-19 |