MAUDE Adverse Event Report: OPTIMA MANUFACTURING, LLC. BACK BRACE; ORTHOSIS LIMB FOR BACK PAIN

Model Number L0650

Device Problem Product Quality Problem (1506)

Patient Problem No Information (3190)

Event Date 05/15/2018

Event Type  malfunction  

Event Description

(b)(6) charged me and insurance (b)(6) for a measly back brace.This is an over charge and they won't return it.It isn't even of good quality and they won't take it back.

• Brand Name: BACK BRACE
• Type of Device: ORTHOSIS LIMB FOR BACK PAIN
• Manufacturer (Section D): OPTIMA MANUFACTURING, LLC.
• MDR Report Key: 7637915
• MDR Text Key: 112441439
• Report Number: MW5078063
• Device Sequence Number: 1
• Product Code: PMV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/22/2018

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 Operator: No Information
• Device Model Number: L0650
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR