MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-10-03 for DEROYAL 15500034 manufactured by Deroyal Industries, Inc..
[56177943]
Investigation findings: the complaint sample was returned. The foam liner has developed holes from rubbing against the uprights. This often happens if the straps are not properly tightened, allowing the leg/liner to move inside the frame during wear/use. This does not require that the end user be "rough" with the product for this to occur. Improper tightening/leg and liner security is the problem root cause: the straps not being properly tightened, has allowed the leg/liner to move inside the frame, friction from the hook inside the upright rubbing against the foam liner has caused the holes. Corrections: replacement product was requested/sent. Corrective action: there is no corrective action required at this time, the issues seen in the attached photographs are related to wear/use, not a vendor defect. Preventive action: there is no preventive action required at this time. No further information is available at this time. We will provide a follow up report if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[56177944]
Detailed description of quality issue: the stays on the sides of the walker boot have worn thru the material and created a pressure ulcer on the patient's side of leg/calf. The patient is an it person and sits at a desk all day, he was not rough with this boot. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: new boot was given and patient is now being treated for his wound.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2016-00025 |
| MDR Report Key | 5993310 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-10-03 |
| Date of Report | 2016-09-29 |
| Date of Event | 2016-07-26 |
| Date Mfgr Received | 2016-09-02 |
| Date Added to Maude | 2016-10-03 |
| 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 | 2016-10-03 |
| Returned To Mfg | 2016-09-13 |
| Model Number | 15500034 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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 | 2016-10-03 |