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..
[177930]
The same health care professional applied the splinting system using the same methods as described in the narrative of report number 1624487-2000-00001. The failure to follow the instructions again could have been the cause of this incident after the splint was applied. After the splint was removed, a slight discoloration of the skin was evident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1624487-2000-00002 |
| MDR Report Key | 261617 |
| Report Source | 06 |
| Date Received | 2000-02-04 |
| Date of Report | 2000-02-02 |
| Date of Event | 2000-01-06 |
| Report Date | 2000-02-02 |
| Date Reported to FDA | 2000-02-02 |
| Date Mfgr Received | 2000-01-06 |
| Date Added to Maude | 2000-02-11 |
| 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 LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 4239387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| 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 | 253372 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE 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 |