MAUDE Adverse Event Report: COMPASS HEALTH BRANDS RICHMAR; APPLICATOR HAMMER 2/5 CM

Model Number 410-115

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Type  malfunction  

Event Description

Soundhead adaptor broken, soundhead is missing pins and must be returned to factory for repair.Picked up to return to mfg.There do appear to be exposed wires from the picture that was provided off the blue wire.The connector is missing on one side and the pins are bent and two are completely missing.

• Brand Name: RICHMAR
• Type of Device: APPLICATOR HAMMER 2/5 CM
• 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: 12851370
• MDR Text Key: 286238852
• Report Number: 3012316249-2021-00033
• Device Sequence Number: 1
• Product Code: IMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K01284830
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/22/2021

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 Model Number: 410-115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1