MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-07-21 for DEROYAL 15500043 manufactured by Deroyal Industries, Inc..
[50239310]
Investigation findings: the customer was contacted to obtain further information. The customer had a walker boot with the inside liner ripping due to hook/loop strap, she did not know the part number of this original walker boot. She originally called in to order a new liner for her walker boot. However, those liners are not sold individually. Instead she was sent a new boot. This new boot is the subject of this complaint. The customer stated the following: the toe guard of the complaint sample was too close to her toes and that it touched the toes and caused discomfort. She also stated that the toe guard on both original and new boot were set to the longest setting. The foot part of the complaint sample was narrower than the original boot she was given. This was also uncomfortable. The original boot was flat on the floor when she stood up. The complaint sample was not flat and it caused her to shift to the side the original boot was a size medium. The lot number of the original sample was 5214. The complaint sample was received. It was confirmed the complaint sample was also a size medium. Quality control was unable to find any error/defect with the returned sample. This product is purchased from an outside vendor and is not made by deroyal. Throughout the history of the product, the vendor has made several changes to improve the design. Based on a review of the inventory, the lot of the complaint sample was1216. The lot number of the (original) boot that was preferred by the customer was 5214. It appears that the original boot received by the customer was a newer version than the replacement boot. The new versions have longer toe straps and lifted d-rings, which helps to "open up" the foot bed. This is why the customer felt more comfortable with her original boot and found the replacement boot uncomfortable. The customer prefers the newer version, and felt that it was more comfortable/roomy. The "adverse patient event" complaint to sales ratio for this product is (b)(4). Root cause: the original boot received by the customer was a newer version than the replacement boot. The new versions have longer toe straps and lifted d-rings, which helps to "open up" the foot bed. This is why the customer felt more comfortable with her original boot and found the replacement boot uncomfortable. The customer prefers the newer version, and felt that it was more comfortable/roomy. Corrections: the customer was able to keep the foam liner of the replacement boot and got the original boot frame back. She stated that she was satisfied. Corrective action: there is no corrective action required at this time, no vendor defect found, the differences in the two boots was related to product changes/improvements. 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
[50239311]
The quality issue details and the outcome details section copied below are responses given by the initial reporter to the deroyal complaint questionnaire. 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: this was a quality replacement for a liner that was destroyed by the velcro straps of previous boot. This replacement which is the same size is too narrow and too short. Customer states boot is rubbing her foot where the brackets are attached inside the boot and causing bruising. How was the quality issue was identified? By actual use. How was the product being used? As usual. 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: irritation, reaction, rash. Details of irritation, reaction, rash (severity, medical treatment, etc. ): bruising. 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: customer reported to deroyal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2016-00018 |
| MDR Report Key | 5813706 |
| Report Source | CONSUMER |
| Date Received | 2016-07-21 |
| Date of Report | 2016-07-21 |
| Date of Event | 2016-06-22 |
| Date Facility Aware | 2016-06-28 |
| Report Date | 2016-06-22 |
| Date Reported to Mfgr | 2016-06-22 |
| Date Mfgr Received | 2016-06-22 |
| Date Added to Maude | 2016-07-21 |
| 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 | 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 | 2016-07-21 |
| Returned To Mfg | 2016-07-05 |
| Model Number | 15500043 |
| 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 | 2016-07-21 |