MAUDE Adverse Event Report: HEALTHPLUS QUICK CHANGE CRUTCH ADULT 9153618192; TIPS AND PADS, CANE, CRUTCH AND WALKE

Model Number 8115-A

Device Problem Unstable (1667)

Patient Problem Fall (1848)

Event Date 09/23/2014

Event Type  Injury  

Event Description

End user's wife advised when her husband was walking in the kitchen the (b)(4) crutches wobbled and he fell.No apparent injuries, no medical attention sought.

Manufacturer Narrative

Initial mfg report # 1531186-2014-04910 was submitted to the fda on 10/17/2014.Additional information has been obtained for the report but due to invacare's updated trackwise system a normal follow-up report could not be transmitted through normal channels.(b)(4).

• Brand Name: QUICK CHANGE CRUTCH ADULT 9153618192
• Type of Device: TIPS AND PADS, CANE, CRUTCH AND WALKE
• Manufacturer (Section D): HEALTHPLUS; handan ; CH
• MDR Report Key: 4408039
• MDR Text Key: 5304721
• Report Number: 1531186-2015-00188
• Device Sequence Number: 1
• Product Code: INP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/17/2014,09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2015
• Is this an Adverse Event Report?: Yes
• 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: 10/17/2014
• Distributor Facility Aware Date: 09/25/2014
• Device Age: 3 MO
• Date Report to Manufacturer: 10/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 68