MAUDE Adverse Event Report: UNKNOWN CRUTCH; 890.3150

Model Number 8115-A

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

End user states that the piece at the bottom of the crutch, that holds the 3 pieces together, keeps coming off.

• Brand Name: CRUTCH
• Type of Device: 890.3150
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4062623
• MDR Text Key: 16559644
• Report Number: 1531186-2014-03838
• Device Sequence Number: 1
• Product Code: IPS
• 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: 09/04/2014,08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2014
• 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: 09/04/2014
• Distributor Facility Aware Date: 08/12/2014
• Date Report to Manufacturer: 09/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 122