MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-13 for DEROYAL WRIST SPLINT 23-325A-04-CFSM manufactured by Deroyal Industries, Inc..
[43328513]
Investigation findings: the complaint sample was not returned. The correct lot number was not listed in the complaint. No information was given about the products wear/use. Contact was made by ra to try to retrieve the complaint sample, however it has not been returned at this time. Un-released product on hand was inspected and no manufacturing defect/error was found. Root cause: investigator was unable to determine root cause as the sample was not returned. Corrections: credit was requested by user facility and issued by deroyal. Corrective action: there is no action required at this time, the complaint sample has not been returned, and no issues or defects were found in house. Preventive action: there is no action required at this time, the complaint sample has not been returned, and no issues or defects were found in house. 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
[43328514]
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: (b)(6)-replaced this patient's large, right 8in wrist splint because the metal part was coming out and causing her pain when she would wear the brace. How was the quality issue was identified? By actual use. How was the product being used? On the hand. 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 equipment? No. Outcome details: outcome(s) attributed to quality issue: none. Person(s) affected by outcome(s) checked above: none. 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: patient was given a new brace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1123071-2016-00001 |
| MDR Report Key | 5574832 |
| Date Received | 2016-04-13 |
| Date of Report | 2016-04-13 |
| Date of Event | 2016-03-21 |
| Report Date | 2016-03-21 |
| Date Reported to Mfgr | 2016-03-21 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2016-04-13 |
| 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 | 164 GILES HOLLOW ROAD |
| Manufacturer City | ROSE HILL VA 24281 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 24281 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL WRIST SPLINT |
| Generic Name | WRIST SPLINT, SUEDE LTHRET 8", LACE UP CLOSURE, RT, L |
| Product Code | ILH |
| Date Received | 2016-04-13 |
| Model Number | 23-325A-04-CFSM |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-04-13 |