MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2013-05-03 for DEROYAL OPB3433-R manufactured by Deroyal Industries, Inc..
[3167611]
A sales representative reported that a back support caused a reddened area on the patient's back.
Patient Sequence No: 1, Text Type: D, B5
[10768962]
Deroyal: the sample reported was not returned for evaluation. Inventory was reviewed with no defects found. This product is latex free. A root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1123071-2013-00001 |
| MDR Report Key | 3108829 |
| Report Source | 00 |
| Date Received | 2013-05-03 |
| Date of Report | 2013-04-05 |
| Date of Event | 2013-04-05 |
| Date Facility Aware | 2013-04-05 |
| Report Date | 2013-04-05 |
| Date Reported to Mfgr | 2013-04-05 |
| Date Mfgr Received | 2013-04-05 |
| Date Added to Maude | 2013-05-20 |
| 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 | 0 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TX 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 164 GILES HOLLOW ROAD |
| Manufacturer City | ROSE HILL VA 24281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | IPY - ORTHOSIS, LUMBO-SACRAL |
| Product Code | IPY |
| Date Received | 2013-05-03 |
| Catalog Number | OPB3433-R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | ROSE HILL VA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-03 |