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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MIZUHO WILSON FRAME PAD SET; PROTECTOR, SKIN PRESSURE
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MIZUHO ORTHOPEDIC SYSTEMS, INC. MIZUHO WILSON FRAME PAD SET; PROTECTOR, SKIN PRESSURE Back to Search Results
Catalog Number REF # 5319-37
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
Patient placed prone on wilson frame on a temperpedic pad set mfrg., for mizuho osi for spine surgery.Surgery lasted 3 hrs 13 min.Post surgery patient had large pressure areas on bil., flank/hip requiring lengthy outpatient wound care.This is the 1st occurrence we have had using this device.Pt had no relevant history, but informed us he sweats profusely, as does his brother who had a similar incident at another facility while prone, resulting in an injury to his forehead.We assessed every potential cause, (eg.Positioning, drapes, skin prep solution, solution pooling, etc.) and could not find cause for the injury.Estimate of duration: 3 months; still ongoing.Diagnosis for use: spinal stenosis with listhesis.Fda safety report id# (b)(4).
 
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Brand Name
MIZUHO WILSON FRAME PAD SET
Type of Device
PROTECTOR, SKIN PRESSURE
Manufacturer (Section D)
MIZUHO ORTHOPEDIC SYSTEMS, INC.
union city CA 94587
MDR Report Key10194677
MDR Text Key196600331
Report NumberMW5095201
Device Sequence Number1
Product Code FMP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/20/2019
Device Catalogue NumberREF # 5319-37
Device Lot NumberDEL/19-02-20
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight93
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