MAUDE Adverse Event Report: HEALTH PLUS HEALTH & MEDICAL CRUTCH; 890.3150

Model Number 8115

Device Problems Break (1069); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Customer alleged that the unit has a broken wing nut.

• Brand Name: CRUTCH
• Type of Device: 890.3150
• Manufacturer (Section D): HEALTH PLUS HEALTH & MEDICAL; 24310 moulton pkwy; unit g; laguna woods CA 92653
• MDR Report Key: 3941493
• MDR Text Key: 4598941
• Report Number: 1531186-2014-02582
• Device Sequence Number: 1
• Product Code: IPR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 07/17/2014,06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2014
• Distributor Facility Aware Date: 06/10/2014
• Date Report to Manufacturer: 07/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other