MAUDE Adverse Event Report: HEALTHPLUS CRUTCH; 890.3150

Model Number 8115T

Device Problem Product Quality Problem (1506)

Patient Problem Skin Tears (2516)

Event Type  No Answer Provided  

Event Description

Dealer stated that due to where the 2 metal pieces of the 8115t crutch meet, the end user sustained a cut on the inside of his left arm, by his elbow.

• Brand Name: CRUTCH
• Type of Device: 890.3150
• Manufacturer (Section D): HEALTHPLUS; handan ; CH
• MDR Report Key: 4151092
• MDR Text Key: 4772748
• Report Number: 1531186-2014-04785
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 10/08/2014,10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 8115T
• 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: 10/08/2014
• Distributor Facility Aware Date: 10/01/2014
• Device Age: 11 MO
• Date Report to Manufacturer: 10/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other