MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-22 for DEROYAL 1-524A-04-CFSM 86275 manufactured by Deroyal Industries, Inc..
[26742970]
Investigation findings: the returned product is very well worn. The liner developed several holes during wear and use. There were two holes at the top of the boot and one at the heel (see attached files (b)(4)). These holes go all the way through the foam liner, allowing the leg to be exposed to the hook tabs that are placed inside the frame to secure the liner to the shell. These holes form during wear/use when the straps are not properly tightened. Loose straps allow the liner/leg to move/rub against the hook tabs inside the shell, causing the foam material to break down. There was no vendor defect was found. Correction: credit was requested/issued. Root cause analysis: the complaint investigator found no vendor or manufacturing defect. It appears that the straps may not have been tightened enough to eliminate leg/liner movement within the shell. Corrective action and/or systemic correction action taken: there is no action required at this time, no vendor/manufacturing defect was found. Preventive action: there is no action required at this time, since no vendor or manufacturing defect was found.
Patient Sequence No: 1, Text Type: N, H10
[26742971]
Below is a copy of the complaint call questions asked by deroyal about the event and the corresponding responses made by the initial reporter. When did quality issue occur? During use. Who was using or operating the product when the quality issue occurred? Patient was a medical procedure involved? No. Did the quality issue cause a delay in the medical procedure? Not applicable. Detailed description of quality issue: i replaced this patient's large, tall pneumatic walking boot because the material was coming apart at the heel and causing pain. The pain was on the heel. There was no injury or blister reported. How was the quality issue was identified? By actual use. How was the product being used? On the foot. 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. 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 | 1060680-2015-00041 |
| MDR Report Key | 5095286 |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-22 |
| Date of Event | 2015-08-28 |
| Date Facility Aware | 2015-08-28 |
| Report Date | 2015-08-28 |
| Date Reported to Mfgr | 2015-08-28 |
| Date Mfgr Received | 2015-08-28 |
| Date Added to Maude | 2015-09-22 |
| 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 LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621013 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37849 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL |
| Generic Name | FULL SHELL WALKER 2, LARGE |
| Product Code | KNP |
| Date Received | 2015-09-22 |
| Returned To Mfg | 2015-09-10 |
| Model Number | 1-524A-04-CFSM |
| Catalog Number | 86275 |
| 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 | 2015-09-22 |