MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-20 for DEROYAL 157-03 manufactured by Deroyal Industries, Inc.
[32261301]
Please note that even though the conclusion chosen was manufacturing deficiency. The problem was caused from a raw material used to make the brace that is purchased from an outside vendor. Investigation findings: complaint sample was received. The wires that are part of the boa fastening system were frayed (see file "figure 1 boa wire pic"). Since the lot number given (30465618) the manufacturing date was traced. This was manufactured on 01/14/2013. During the time this product was for this same issue described. That the wires on the back support are fraying and have cut the patient or snagged him a few times. The wires described in the complaint are part of the (b)(4) closure system. (b)(4) is a closure system used in medical and sport devices. It is owned by (b)(4). This system is purchased from (b)(4) and used as a raw material for many of our bracing products. A supplier notification letter (snl) was issued to (b)(4) to request they investigate this problem with their wires. (b)(4) performed an investigation and found that there was a flaw in the lace (wire) obtained from their suppliers. As a result the (b)(4) representative stated to deroyal qc investigator by email the following: there was a bad batch of wires that got out to the market. Due to the small size of the issue, a formal corrective action was not filed. They had an informal communication with their wire vendor. Close inspections were implemented and no other issues had been found by them. Correction: replacement product was sent to customer. Root cause analysis: this is very likely to the vendor issue that we previously had, as the manufacturing date matches the time period when this problem occurred. Corrective action and/or systemic correction action taken: as discussed above, the vendor has already been contacted about this and they performed an investigation to solve the problem. There have been no other issues on wire fraying this year. No new action is required at this time. Preventive action: there is no preventative action needed 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
[32261302]
Information below was copied from complaint call text. 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. Detailed description of quality issue: the wires on back support are fraying and have cut the patient or snagged him a few times. How was the quality issue was identified? By actual use. How was the product being used? As a back brace. Was it the initial use of the product? No. 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. Known pre-existing condition(s) of person(s) affected: none specified. Was the incident reported to the fda? No. Follow up questions were asked as to the level of injury. The questions and corresponding answers from the user facility are below: what part of the body were the cuts on? On patients fingers and forearms. How many cuts were there? Multiple little cuts. What was the severity of the cuts? Minor cuts and irritation to the forearms like a bad rash or pin pricks. Are there any pictures? No. How were these cuts treated? Normal first aid treatment. Are the wires mentioned part of the boa system or is it something else? It was the wire from the boa dial that was fraying and causing irritation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006851902-2015-00004 |
| MDR Report Key | 5240336 |
| Date Received | 2015-11-20 |
| Date of Report | 2015-11-20 |
| Date of Event | 2015-10-21 |
| Date Facility Aware | 2015-10-21 |
| Date Mfgr Received | 2015-10-21 |
| Date Added to Maude | 2015-11-20 |
| 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 TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653621013 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | KM7 AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BUILDING 18 |
| Manufacturer City | SANTIAGO, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DEROYAL |
| Generic Name | BACK SUPPORT, PROLIGN? EXT, 25 DEGREE, BOA, M |
| Product Code | IPY |
| Date Received | 2015-11-20 |
| Returned To Mfg | 2015-11-03 |
| Model Number | 157-03 |
| Lot Number | 30465618 |
| 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 LN POWELL TN 37849 US 37849 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-20 |