MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-21 for DEROYAL FOOT/ANKLE ORTHOSIS 1-507A-05 manufactured by Deroyal Industries, Inc..
[44182838]
Investigation findings: the complaint sample was returned. The product looked new and unused. It is possible that it was only worn during fitting. No defects were reported in the complaint, only that is was uncomfortable on the leg. The product was inspected and no vendor/manufacturing defect was found. Root cause: the investigator was unable to determine root cause as no manufacturing defect/ or issue was found. It is possible that this boot was just not well suited to the end users injury and/or condition. Corrections: replacement product was requested and sent. Corrective action: there is no action required at this time, the returned sample was not found to be defective. Preventive action: there is no action required at this time, the returned sample was not found to be defective. No further information is available at this time. We will provide follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[44182839]
Quality issue details : date of occurrence: (b)(6) 2016. When did quality issue occur? During use. Who was using or operating the product when the quality issue occurred? Patient/end consumer. Was a medical procedure involved? No. Name of medical procedure: not applicable. Did the quality issue cause a delay in the medical procedure? Not applicable. Detailed description of quality issue: patient said the brace was very painful. Extra pads did not help. They returned the product - said that the leg hurt too much. Patient was put in a cast. How was the quality issue was identified? By actual use. How was the product being used? Normal use. Was it the initial use of the product? Yes. Was the product modified from the original condition supplied by deroyal? No. Was the product connected to or used in conjunction with other devices or equipment? No. Outcome details: outcome(s) attributed to quality issue: none. Person(s) affected by outcome(s) checked above: patient. Known pre-existing condition(s) of person(s) affected: none specified. Was the incident reported to the fda? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: please replace the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2016-00004 |
| MDR Report Key | 5594869 |
| Date Received | 2016-04-21 |
| Date of Report | 2016-04-18 |
| Date of Event | 2016-04-02 |
| Report Date | 2016-04-05 |
| Date Reported to Mfgr | 2016-04-05 |
| Date Mfgr Received | 2016-04-02 |
| Date Added to Maude | 2016-04-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. MARIAN VARGAS |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621013 |
| Manufacturer G1 | ELITE ORTHOPAEDICS, INC. |
| Manufacturer Street | 1535 SANTA ANITA AVENUE |
| Manufacturer City | SOUTH EL MONTE CA 91733 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91733 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL FOOT/ANKLE ORTHOSIS |
| Generic Name | WALKER BOOT |
| Product Code | ITW |
| Date Received | 2016-04-21 |
| Returned To Mfg | 2016-04-11 |
| Model Number | 1-507A-05 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-21 |