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

Model Number 410-115

Device Problem Break (1069)

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

Event Type  malfunction  

Event Description

The fisher connector is broken, customer reports exposed wires.

• Brand Name: RICHMAR
• Type of Device: APPLICATOR HAMMER
• 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: cynthia toney ; 6753 engle road; middleburg heights 44130 ; 4402682110
• MDR Report Key: 11563931
• MDR Text Key: 244398138
• Report Number: 3012316249-2021-00013
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 410-115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Date Manufacturer Received: 03/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2016
• 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