MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-02-04 for DEROYAL C24250060 manufactured by Deroyal Industries, Inc..
[20438902]
After splinting material was applied to the pt's posterior right leg, pt complained of discomfort. The material was removed, and the skin was noted to be red in color. The pt was treated for a first degree burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1624487-2000-00001 |
| MDR Report Key | 261595 |
| Report Source | 06 |
| Date Received | 2000-02-04 |
| Date of Report | 2000-02-02 |
| Date of Event | 2000-01-04 |
| Date Facility Aware | 2000-01-04 |
| Report Date | 2000-02-02 |
| Date Reported to FDA | 2000-02-02 |
| Date Mfgr Received | 2000-01-04 |
| Date Added to Maude | 2000-02-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 4239387828 |
| Manufacturer G1 | CARAPACE INC. |
| Manufacturer Street | 2701 W CONCORD ST |
| Manufacturer City | BROKEN ARROW OK 74012117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74012 1178 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | UNIVERSAL SPLINTING SYSTEM |
| Product Code | LGF |
| Date Received | 2000-02-04 |
| Returned To Mfg | 2000-01-12 |
| Model Number | NA |
| Catalog Number | C24250060 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 253350 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LN POWELL TN 37849 US |
| Baseline Brand Name | DEROYAL |
| Baseline Generic Name | SPLINTING SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | C24250060 |
| Baseline ID | NA |
| Baseline Device Family | CASTING PRODUCTS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-02-04 |