MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-28 for DEROYAL 5066-48 manufactured by Deroyal Industries, Inc..
[49282627]
Investigation findings: the complaint samples were returned (3 each, not 4 as listed in the complaint information). The products do not have a mold or mildew odor, but they do have discoloration as seen in the attached photo (attachment 1). This discoloration is not visible on the laces, hook or loop it is only seen on the body of the brace. The returned package is not wet and, it does not appear to have been wet. There is no mold/mildew visible inside/on the box. The sales order listed shipped from the distribution center almost a year ago (9/2015) and the product/lots listed on that order for part 5066-48 was lot 29777569. This lot was produced on 10/02/2012. Current inventory was reviewed, lot 40131574 (14 each on hand). There were no issues of this nature found. No other complaints of this nature have been filed for this product. Root cause: unable to determine root cause. (b)(4) will continue to monitor trends for this failure and will recognize in the future if it transitions from an isolated report to a recurring issue. Corrections: replacement product was requested and sent. Corrective action: there is no corrective action required at this time, no issues were found in house. 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
[49282628]
The quality issue details and the outcome details section copied below are responses given by the initial reporter to the (b)(4) complaint questionnaire. Quality issue details: date of occurrence: (b)(6) 2016. When did quality issue occur? Before use. Who was using or operating the product when the quality issue occurred? Health professional. 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: when they opened the plastic wrap on each splint, there was mold inside on each one. How was the quality issue was identified? By visual inspection. How was the product being used? Wrist. 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. Outcome details: outcome(s) attributed to quality issue: none. Person(s) affected by outcome(s) checked above: facility employee. Known pre-existing condition(s) of person(s) affected: n/a. Was the incident reported to the fda? No. Detailed description of outcome(s), including information regarding injury or any additional treatment/intervention required: n/a.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010452421-2016-00011 |
| MDR Report Key | 5754660 |
| Date Received | 2016-06-28 |
| Date of Report | 2016-06-27 |
| Date of Event | 2016-05-31 |
| Date Facility Aware | 2016-05-31 |
| Report Date | 2016-05-31 |
| Date Reported to Mfgr | 2016-05-31 |
| Date Mfgr Received | 2016-05-31 |
| Date Added to Maude | 2016-06-28 |
| 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 | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | VILLA CANALES, GUATEMALA 01065 |
| Manufacturer Country | GT |
| Manufacturer Postal Code | 01065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL |
| Generic Name | WRIST SPLINT, CANVAS |
| Product Code | ILH |
| Date Received | 2016-06-28 |
| Returned To Mfg | 2016-06-14 |
| Catalog Number | 5066-48 |
| Lot Number | 29777569 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2016-06-28 |