DRIVE MEDICAL

Report

• Report Number: 2438477-2016-00058
• Event Type: Injury
• Date Received: November 22, 2016
• Date of Event: October 22, 2016
• Report Date: October 24, 2016
• Manufacturer: KAP MEDICAL
• Product Code: FNM
• Adverse Event: Yes
• Report Source: Distributor report
• Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

DRIVE DEVILBISS HEALTHCARE RECEIVED NOTICE ABOUT THIS CLAIM FROM ENDUSER'S WIFE, INVOLVING A MATTRESS, A PRODUCT DISTRIBUTED BY DRIVE DEVILBISS HEALTHCARE. WHILE THE ENDUSER WAS IN BED, HIS ARM ALLEGEDLY SLIPPED INTO THE GULLY BETWEEN THE MATTRESS AND BOLSTER DURING THE ROTATION PERIOD, CAUSING HIM TO INJURE HIS ARM. THE SKIN ON HIS ARM HAD PEELED OFF AND HE WAS BLEEDING. ENDUSER'S WIFE WILL NOT BE RETURNING THE MATTRESS BECAUSE SHE WANTS TO CONTINUE USING IT. THIS REPORT IS BASED ON THE INFORMATION THAT WAS PROVIDED BY ENDUSER'S WIFE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
771865	DRIVE MEDICAL	MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE	FNM	KAP MEDICAL	LS9500

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	FULL ELECTRIC BED

Terms

Patient problem · 1

• Injury

Product problems · 1

• Adverse Event Without Identified Device or Use Problem

Type of report · 1

• Initial submission