MAUDE Adverse Event Report: HEALTHPLUS CRUTCH; 890.3150

Model Number 8115-A

Device Problem Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2014

Event Type  No Answer Provided  

Event Description

Consumer states that a plastic sliding piece kept sliding to the bottom and made the crutches very wobbly and unsecured.Consumer attaches a screw to holding this sliding piece in place.No additional information provided.

• Brand Name: CRUTCH
• Type of Device: 890.3150
• Manufacturer (Section D): HEALTHPLUS; handan ; CH
• MDR Report Key: 4168191
• MDR Text Key: 5090202
• Report Number: 1531186-2014-04894
• 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: Patient
• Type of Report: Initial
• Report Date: 10/13/2014,09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8115-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/13/2014
• Distributor Facility Aware Date: 09/24/2014
• Device Age: 6 MO
• Date Report to Manufacturer: 10/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other