MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-30 for SUPER SPLINT * 2862 manufactured by Osi.
[19897956]
Pt required splinting for treatment of left ankle fracture. After splinting material applied, pt complained of extreme heat. Second degree burns noted by facility. Pt transferred for surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1024855 |
| MDR Report Key | 391621 |
| Date Received | 2002-04-30 |
| Date of Report | 2002-04-22 |
| Date of Event | 2002-04-11 |
| Date Added to Maude | 2002-05-06 |
| 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 |
| 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 | SUPER SPLINT |
| Generic Name | FOAM AND FLANNEL SPLINTING SYSTEM |
| Product Code | FYH |
| Date Received | 2002-04-30 |
| Model Number | * |
| Catalog Number | 2862 |
| Lot Number | 1283 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 380657 |
| Manufacturer | OSI |
| Manufacturer Address | 30031 AHERN AVE UNION CITY CA 945871234 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-04-30 |