FDA Adverse Event Injury Summary report: N

QUICKIE QRI

MDR report key: 7656826 · Received July 2, 2018

Report

Report Number: 9616084-2018-00008
Event Type: Injury
Date Received: July 2, 2018
Date of Event: June 13, 2018
Report Date: June 13, 2018
Manufacturer: SUNRISE MEDICAL PRIVADA MISIONES
Product Code: IOR
PMA / PMN Number: K123975
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

ON (B)(6) 2018 THE END USER ALSO STATED THAT HE ORIGINALLY DECLINED THE ANTI-TIP WHEELS ON HIS CHAIR AS HE FELT THEY WERE TOO PRICEY AND FELT AT THE TIME THAT HE DID NOT NEED THEM. THE END USER STATED THAT HE IS JUST CALLING TO SEE IF SUNRISE MEDICAL CAN GIVE HIM ANTI-TIPS OR IF THERE WAS ANYTHING THAT WE CAN DO FOR HIM. HE STATED THAT HE DOES NOT WANT TO GET THEM THROUGH A DEALER BECAUSE HE FEELS THEY ARE "TOO PRICEY". SUNRISE MEDICAL'S CUSTOMER SERVICE REPRESENTATIVE ADVISED THE END USER THAT WE WERE UNABLE TO SEND OUT PARTS DIRECTLY TO THE PUBLIC, AND ENCOURAGED THE END USER TO CONTACT A DEALER. SUNRISE MEDICAL IS FILING THIS MDR TO REPORT THE INJURY CLAIM ONLY. THERE IS NO INDICATION FROM THE COMPLAINT THAT THE SUBJECT WHEELCHAIR MALFUNCTIONED OR IS DEFECTIVE. THE END USER TAKES FULL RESPONSIBILITY FOR THIS INCIDENT SINCE HE CHOSE NOT TO ADD THE ANTI-TIP WHEELS TO HIS WHEELCHAIR. NO FURTHER INVESTIGATION WILL BE PERFORMED BY SUNRISE MEDICAL.

Description of Event or Problem · 1

THE END USER CALLED TO ADVISE THAT RECENTLY HE WAS GOING UP A SMALL RAMP AND FELL BACKWARD. HE CLAIMED HIS HEAD WAS INJURED AND GOT A TOTAL OF 7 STITCHES. HE STATED THAT HE KNOWS IT WAS HIS FAULT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
499493	QUICKIE QRI	MANUAL WHEELCHAIR	IOR	SUNRISE MEDICAL PRIVADA MISIONES	EIR5

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention