MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-10-05 for DEROYAL 1-502A-98 manufactured by Deroyal Industries, Inc..
[56448203]
Supplemental information: the complaint text states that the complaint item was an ankle stirrup with an air bladder. However, the part number listed in the complaint entry, 1-502a-98, is a walking boot. When the complaint sample was received by the qc investigator, it was shown to be an ankle stirrup without an air bladder. The qc investigation report below was performed on the complaint sample returned, an ankle stirrup without an air bladder. Qc investigation: investigation findings: the complaint sample was returned. The product shows sign of wear/use. The returned sample is manufactured to current specifications the memory foam padding completely covers the shell and is not damaged/broken down. There were no manufacturing defects/errors found; root cause: investigator is unable to determine root cause as there were no manufacturing defect/issues found; corrections: credit was requested/issued; corrective action: there is no corrective action required at this time, the returned sample was not found to be defective; preventive action: there is no preventive 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
[56448204]
No injury was reported. Detailed description of quality issue: replaced patient's ankle stirrup brace because the padding was deflating and causing the plastic to rub skin. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: patient was given a new brace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2016-00026 |
| MDR Report Key | 5999347 |
| Report Source | USER FACILITY |
| Date Received | 2016-10-05 |
| Date of Report | 2016-10-04 |
| Date of Event | 2016-07-01 |
| Date Mfgr Received | 2016-09-08 |
| Date Added to Maude | 2016-10-05 |
| 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 | MS. ELIZABETH REED |
| Manufacturer Street | 200 DEBUSK LN |
| Manufacturer City | POWELL 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621256 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1703 HWY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | ANKLE STIRRUP |
| Product Code | ITW |
| Date Received | 2016-10-05 |
| Returned To Mfg | 2016-09-19 |
| Model Number | 1-502A-98 |
| 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 | 1703 HWY 33 SOUTH NEW TAZEWELL TN 37825 US 37825 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-05 |