MIZUHO WILSON FRAME PAD SET
Received Jun 24, 2020
Report MW5095201 · MDR key 10194677
Device
Generic name
Protector, Skin Pressure
Manufacturer
Mizuho Orthopedic Systems, Inc.Catalog number
REF # 5319-37
Lot number
DEL/19-02-20
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
- Injury
Narrative
Description of Event or Problem
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).