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

Model Number 410-115

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

The connector is missing (broken off).Plastic casing is missing, blue wire that connects to white end has a piece of wire visible.

• 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: 11655185
• MDR Text Key: 245105174
• Report Number: 3012316249-2021-00017
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• 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?: No
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1