PILLOW, GENTLETOUCH 7 INCH RT, 12/CS
Received Feb 16, 2024 · Event occurred Sep 1, 2023
Report 2921578-2024-00002 · MDR key 18722599
Device
Generic name
Patient Positioning Pillow
Manufacturer
Mizuho Orthopedic Systems, Inc.Model number
1937DZCatalog number
1937DZ
Product problems
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- Insufficient Device Problem Information
Patient
NA · Unknown
- Bruise/Contusion
- Bruise/Contusion
Narrative
Description of Event or Problem
MODERATE TO SEVERE BRUISES ON THE FACE REPORTED IN FEW PATIENTS USING GENTLE TOUCH PILLOWS.
Additional Manufacturer Narrative
BASED ON THE INFORMATION OBTAINED FROM THE INVESTIGATION, THERE WERE NO PROBLEMS WITH THE DEVICE FOUND. THE REPORTED ADVERSE EVENTS ARE PRESSURE INJURIES OBSERVED IN PATIENTS THAT WERE IN PRONE POSITION DUE TO THE REQUIREMENTS OF THE SURGERY. THE INSTRUCTIONS FOR USE PROVIDES NECESSARY WARNINGS, CAUTIONARY NOTES AND OPTIONS FOR USERS TO BE INFORMED ON SELECTION OF PROPER PRE-OPERATIVE AND INTRA-OPERATIVE PROCEDURES. LIKEWISE, EUROPEAN PRESSURE ULCER ADVISORY PANEL, NATIONAL PRESSURE INJURY ADVISORY PANEL AND PAN PACIFIC PRESSURE INJURY ALLIANCE GUIDELINES (2019) RECOMMEND GUIDELINES PERTAINING TO POTENTIAL RISK FACTORS AND APPLICABLE PREVENTIVE MEASURES. THE SPECIFIC ROOT CAUSE IS NOT ESTABLISHED AS VARIOUS FACTORS SUCH AS PRE-EXISTING PHYSIOLOGICAL OR ANATOMICAL PATIENT CONDITIONS, PATIENT POSITIONING TECHNIQUES, DURATION OF PATIENT POSITIONING, INTERATION/REACTIVITY OF PATIENT SKIN WITH THE DEVICE MAY CONTRIBUTE IN THE OBSERVED PATIENT PRESSURE INJURIES. AN EDUCATIONAL LETTER WAS SHARED WITH THE HOSPITAL THAT SUMMARIZES THE POTENTIAL RISKS RELATED TO PRESSURE INJURIES AND APPLICABLE MITIGATION STRATEGIES.
Description of Event or Problem
MODERATE TO SEVERE BRUISES ON THE FACE REPORTED IN FEW PATIENTS USING GENTLETOUCH PILLOWS.