MAUDE Adverse Event Report: SIZEWISE SIZEWISE STRETCHER PAD; STRETCHER MATTRESS. SW ENVY NP GURNEYL STRETCHER PAD

Device Problem Device Contamination with Body Fluid (2317)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/26/2015

Event Type  Injury  

Event Description

Patient placed on stretcher in room.The stretcher mattress appeared visually intact and clean.When she rose from the stretcher, patient noted to be covered with blood on her back.Blood had seeped from the mattress through the mattress cover and sheet.Patient exposed to blood from another patient.Manufactured in january 2011.

• Brand Name: SIZEWISE STRETCHER PAD
• Type of Device: STRETCHER MATTRESS. SW ENVY NP GURNEYL STRETCHER PAD
• Manufacturer (Section D): SIZEWISE; kansas city MO
• MDR Report Key: 5061665
• MDR Text Key: 25240039
• Report Number: MW5056020
• Device Sequence Number: 1
• Product Code: IKY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Report Date: 08/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR