MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-09-13 for DEROYAL 350LL manufactured by Deroyal Estonia Ou.
[3719941]
The patient reported that the brace made her arm break out.
Patient Sequence No: 1, Text Type: D, B5
[11105021]
Deroyal: the reported device has not been returned at this time. The investigation into the root cause is in process. This product does not contain natural rubber latex.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1060680-2013-00006 |
| MDR Report Key | 3360044 |
| Report Source | 04 |
| Date Received | 2013-09-13 |
| Date of Report | 2013-08-20 |
| Date of Event | 2013-08-16 |
| Date Facility Aware | 2013-08-16 |
| Report Date | 2013-08-20 |
| Date Reported to Mfgr | 2013-08-20 |
| Date Mfgr Received | 2013-08-20 |
| Date Added to Maude | 2013-10-01 |
| 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 | 8659387828 |
| Manufacturer G1 | DEROYAL ESTONIA OU |
| Manufacturer Street | HASIGRU 11 |
| Manufacturer City | TALLINN 10615 |
| Manufacturer Country | EN |
| Manufacturer Postal Code | 10615 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | SPLINT, HAND, AND COMPONENTS |
| Product Code | ILH |
| Date Received | 2013-09-13 |
| Catalog Number | 350LL |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL ESTONIA OU |
| Manufacturer Address | ESTONIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-13 |