MAUDE Adverse Event Report: UNKNOWN CRUTCH; 890.3150

Model Number UNKNOWN

Device Problem Product Quality Problem (1506)

Patient Problem Discomfort (2330)

Event Type  No Answer Provided  

Event Description

End-user stated the unknown crutches caused him to have redness under his arms and almost slipped out from under him.

• Brand Name: CRUTCH
• Type of Device: 890.3150
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 3762557
• MDR Text Key: 17840429
• Report Number: 1531186-2014-01444
• 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: 04/21/2014,03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• 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: 04/21/2014
• Distributor Facility Aware Date: 03/20/2014
• Date Report to Manufacturer: 04/21/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other