MAUDE Adverse Event Report: BETTER BRACING RESPOND QUADRIFLEX; STIMULATOR, MUSCLE, POWERED

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the patient needed pads and the tens unit needed to be repaired.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: RESPOND QUADRIFLEX
• Type of Device: STIMULATOR, MUSCLE, POWERED
• Manufacturer (Section D): BETTER BRACING
• MDR Report Key: 17532539
• MDR Text Key: 321413125
• Report Number: MW5139447
• Device Sequence Number: 1
• Product Code: IPF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1