MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. SOLACE LOW PROFILE BACK BRACE; ORTHOSIS, LUMBO-SACRAL

Model Number 13400007

Device Problem Sharp Edges (4013)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 11/10/2022

Event Type  Injury  

Event 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.Fda safety report id (b)(4).

• Brand Name: SOLACE LOW PROFILE BACK BRACE
• Type of Device: ORTHOSIS, LUMBO-SACRAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.
• MDR Report Key: 15800371
• MDR Text Key: 303799112
• Report Number: MW5113275
• Device Sequence Number: 1
• Product Code: IPY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 13400007
• Device Catalogue Number: 13400007
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ADVIL.
• Patient Outcome(s): Disability
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White