MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-01-31 for DEROYAL 15540006 manufactured by Premier Guard Zhongshan Limited.
[66220298]
Investigation findings: customer complained that the sole cracked in half. There was no patient injury reported. The complaint sample returned. The lot number was found on the sample itself. This issue has been seen before. In 2010, this issue was found and corrected by the vendor on the gluing of the rubber sole bottom. From the lot number the deroyal was able to verify that this product was made before the vendor corrective action was implemented. The complaints (sole ungluing issues) to sales ratio for this line of products (inline and inline air walkers) from 2012 to 2016 is (b)(6). Product in house was inspected and no issues were found. The vendor was issued a supplier corrective action request (scar) for the complaint in question. If vendor investigation leads to any new findings, a follow up report will be filed. Root cause: the root cause is likely from known vendor issues that have already been corrected by the vendor. Corrective action: there is no corrective action required at this time. Preventive action: there is no preventive action required at this time. 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
[66220299]
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. Detailed description of quality issue: customer said that the sole cracked in half. How was the quality issue was identified? By visual inspection. How was the product being used? Therapy. Was it the initial use of the product? Yes. Was the product modified from the original condition supplied by (b)(4)? No. Was the product connected to or used in conjunction with other devices or equipment? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2017-00003 |
| MDR Report Key | 6291355 |
| Report Source | CONSUMER |
| Date Received | 2017-01-31 |
| Date of Report | 2016-12-29 |
| Date of Event | 2016-12-29 |
| Date Mfgr Received | 2016-12-29 |
| Date Added to Maude | 2017-01-31 |
| 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 | WALKING BOOT |
| Product Code | ITW |
| Date Received | 2017-01-31 |
| Returned To Mfg | 2017-01-11 |
| Model Number | 15540006 |
| Lot Number | 0808400 |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PREMIER GUARD ZHONGSHAN LIMITED |
| Manufacturer Address | NO 52, HUAN MAO YI ROAD TORCH DEVELOPMENT ZONE ZHONGSHAN GUANGDONG, 528400 CH 528400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-31 |