MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. BACK SUPPORT, SOLACE, L; ORTHOSIS, LUMBO-SACRAL

Model Number	13400007
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Sharp Edges (4013)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Laceration(s) (1946)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A voluntary medwatch report (#mw5113275) was received on 11/23/2022 reporting an orthopedic doctor ordered a deroyal back brace for the end user.The first day they wore it, the edges of the velcro sliced their arm open twice.Both injuries bled enough that they had to put pressure and bandage them.The ends are hard and sharp, and the end user will not be able to continue using this brace.An inventory check was made by deroyal of product on hand, a total of 3 of the 13400007 solace back support lot number 54423480 were inspected.There were discrepancies identified during this inspection.The side pulls were placed on the opposite sides causing the rough edge of the webbing to be at the top of the pocket, not on the bottom.The sample was not returned to deroyal for evaluation.The medwatch report states the device is available for evaluation but there was no contact information provided.A specific lot number was not provided by the end user.If the complaint product was from the same lot number identified by the inventory check the root cause was determined to be an assembly error during inspection.The side pulls were placed on the opposite sides causing the rough edge of the webbing to be at the top of the pocket, not on the bottom.The following corrective actions have taken place by deroyal: the 3 each found during the inventory check that was assembled incorrectly were reworked into lot number 58370354.The inspector was re-trained on the task of assembling the solace back supports, specifically for products having rough edges.Complaints will be monitored for these types of issues.There have been no other complaints reported for the 13400007 solace back support.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
My orthopedic doctor ordered a deroyal back brace for me.The first day i wore it, the edges of the velcro sliced my arm open twice.Both injuries bled enough that i had to put pressure and bandage them.The ends are hard and sharp, and i will not be able to continue using this brace.

• Brand Name: BACK SUPPORT, SOLACE, L
• Common Device Name: ORTHOSIS, LUMBO-SACRAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 164 giles hollow rd; rose hill VA 24281
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 164 giles hollow rd; rose hill TN 24281
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 15944933
• Report Number: 1123071-2022-00001
• Device Sequence Number: 12561132
• Product Code: IPY
• UDI-Device Identifier: 00749756620994
• UDI-Public: 00749756620994
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 13400007
• Device Catalogue Number: 13400007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown