MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q7; WHEELCHAIR, MECHANICAL

Model Number EIR4

Device Problems Entrapment of Device (1212); Device Tipped Over (2589); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Hernia (2240); Physical Entrapment (2327); Injury (2348)

Event Date 02/13/2014

Event Type  Injury  

Event Description

Sunrise medical was made aware of an adverse event involving a quickie q7 via a letter sent by the end user.The end user is alleging that the wheels "chattered" and flipped him over and dumped him out of his wheelchair.The end user is alleging injury to his right hand that was caught in the spokes of the rear wheel.The end user is also alleging that he received a hernia from the fall and that it is not repairable due to his polio.Additional information is unavailable at this time due to legal involvement.

Manufacturer Narrative

This case is in legal.Sunrise medical is working on obtaining the device involved in this adverse event for an evaluation.If and when the device is returned to sunrise medical, an investigation will be completed and a follow-up report will be filed.

• Brand Name: QUICKIE Q7
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; fresno CA 93727
• Manufacturer Contact: jeremy ybarra ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 3682645
• MDR Text Key: 4293582
• Report Number: 2937137-2014-00007
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123975
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIR4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 02/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention