FDA Adverse Event Injury Summary report: N

QUICKIE 2 LITE

MDR report key: 1910213 · Received November 17, 2010

Report

Report Number: 2937137-2010-00020
Event Type: Injury
Date Received: November 17, 2010
Date of Event: October 21, 2010
Report Date: October 21, 2010
Manufacturer: SUNRISE MEDICAL (US) LLC
Product Code: IOR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE MEDICAL DEVICE HAS NOT YET BEEN RETURNED TO SUNRISE MEDICAL (US) LLC FOR EVALUATION AND IT IS UNKNOWN IF AND WHEN THE MANUFACTURER MAY HAVE THE OPPORTUNITY TO COMPLETE A QUALITY EVALUATION ON THE SUSPECT DEVICE. MANUFACTURER DOES NOT HAVE ALL OF THE DETAILS OF THE ALLEGED REPORTABLE EVENT AT THIS TIME TO COMPLETE OUR INVESTIGATION. A CALL TAG WAS ISSUED AND WE DO ANTICIPATE AN EVALUATION ONCE WE RECEIVE THE WHEELCHAIR FROM THE END USER. THE WHEELCHAIR WAS SHIPPED TO THE DEALER WITHIN SPECIFICATION AND PASSED ALL OF OUR QUALITY CONTROL REQUIREMENTS.

Description of Event or Problem · 1

DEALER CALLED IN ON (B)(6) 2010. THE DEALER STATED THAT THE ALLEGED INCIDENT OCCURRED ON (B)(6) 2010. THE DEALER REPORTED THAT THE CLIENT (END USER) INFORMED HIM THAT HE WAS AT HOME GOING TO HIS KITCHEN FROM HIS BEDROOM WHEN THE FRONT CASTER FORK FELL OFF. AS IT FELL OFF THE CHAIR, THE WHEELCHAIR FELL OVER ON ITS RIGHT SIDE AS YOU SIT IN THE CHAIR. THE END USER CLAIMS HE CALLED AN AMBULANCE BETWEEN THE HOURS OF 5 AND 6 PM CENTRAL STANDARD TIME. END USER STATED THAT HE WAS NOT TRANSPORTED TO THE HOSPITAL. THE DEALER WOULD NOT DISCLOSE THE EXTENT OF THE INJURIES THE END USER ALLEGEDLY SUSTAINED. THE CLIENT ADVISED THE DEALER, HE WAS JUST INTERESTED IN GETTING THE NEW PARTS TO REPAIR HIS CHAIR AND DID NOT REQUEST ANY FOLLOW UP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUICKIE 2 LITE	WHEELCHAIR, MECHANICAL	IOR	SUNRISE MEDICAL (US) LLC	EIQ2N	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Other