FLOTATION CUSHION

MDR report key: 2898394 · Received January 7, 2013

Report

Report Number: 9615350-2013-00002
Event Type: Malfunction
Date Received: January 7, 2013
Report Date: December 5, 2012
Manufacturer: INVACARE TAYLOR STREET
Product Code: KIC
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE MALFUNCTION HAS NOT BEEN CONFIRMED.

Additional Manufacturer Narrative · 1

(B)(4) - FOLLOW UP #001. INITIAL (B)(4) ISSUED MFR. REPORT # 9615350-2013-00002, INDICTING THE BRAND NAME AS AN ALTERNATING PRESSURE AIR FLOTATION MATTRESS, THE CORRECT NAME IS FLOTATION CUSHION; THE COMMON DEVICE NAME AS 880.5550, THE CORRECT DEVICE IS 890.3175; THE MANUFACTURER AS MOTION CONCEPTS WHEN THE MANUFACTURER IS INVACARE TAYLOR STREET. THE FDA REGISTRATION NUMBER WAS REPORTED AS (B)(4) WHEN IN FACT IT IS (B)(4) FOR INVACARE.

Description of Event or Problem · 1

(B)(4). SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER STATES THAT THE OVERLAY HAD A PERMANENT WRINKLE IN IT WHICH CAUSED THE END USER TO HAVE A STAGE TWO PRESSURE SORE IN THE COCCYX AREA. MDR FILED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
6098	FLOTATION CUSHION	890.3175	KIC	INVACARE TAYLOR STREET	ITFG88

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other