MAUDE Adverse Event Report: MUELLER MUELLER HAND BRACES; HANDPIECE (BRACE)

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Information (3190)

Event Date 01/12/2018

Event Type  malfunction  

Event Description

Braces were purchased today.They are not made by the manufacturer.

• Brand Name: MUELLER HAND BRACES
• Type of Device: HANDPIECE (BRACE)
• Manufacturer (Section D): MUELLER
• MDR Report Key: 7199681
• MDR Text Key: 97715721
• Report Number: MW5074602
• Device Sequence Number: 1
• Product Code: IQI
• 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: 01/12/2018

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 55