MAUDE Adverse Event Report: COMPASS HEALTH BRANDS RICHMAR; APPLICATOR AUTOSOUND

Model Number 410-200

Device Problem Loss of or Failure to Bond (1068)

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

Event Type  malfunction  

Event Description

My staff is telling me that the last 2 units we received are having issues with the male bit that goes into the machine.They're explaining to me that the plastic part is loose and it doesn't work as well.Device has visible wires.

• Brand Name: RICHMAR
• Type of Device: APPLICATOR AUTOSOUND
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer Contact: cindy toney ; 6753 engle road; middleburg heights 44130 ; 4402682110
• MDR Report Key: 12497969
• MDR Text Key: 272255386
• Report Number: 3012316249-2021-00028
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/20/2021

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: 410-200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1