PRONE VIEW CUSHION INSERT D28503CE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-26 for PRONE VIEW CUSHION INSERT D28503CE manufactured by Mizuho Osi.

Event Text Entries

[3059484] Pt found to have a skin wound after use of the prone view pillow during prolonged surgery approx 9 1/2 hours. The wound was not evident until the day after surgery. Reason for use: prone position during surgery for lumbar fusion.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5028384
• MDR Report Key: 2892802
• Date Received: 2012-12-26
• Date of Report: 2012-12-26
• Date of Event: 2012-09-11
• Date Added to Maude: 2013-01-04
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: PRONE VIEW CUSHION INSERT
• Generic Name: PRONE VIEW CUSHION INSERT
• Product Code: KME
• Date Received: 2012-12-26
• Model Number: D28503CE
• Catalog Number: D28503CE
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MIZUHO OSI
• Manufacturer Address: 30031 AHERN AVE UNION CITY CA 94587 US 94587

Device Sequence Number: 2

• Brand Name: VIEW PILLOW
• Generic Name: VIEW PILLOW
• Product Code: KME
• Date Received: 2012-12-26
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MIZUHO OSI
• Manufacturer Address: 30031 AHERN AVE UNION CITY CA 94587 US 94587

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2012-12-26