PILLOW, HEADREST, GT, 7 INCH
Received Aug 25, 2021 · Event occurred Aug 13, 2021
Report 2921578-2021-00019 · MDR key 12366583
Device
Generic name
Gentletouch
Manufacturer
Mizuho Orthopedic Systems, Inc.Model number
1937Catalog 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
45 YR · Unknown
- Erythema
- Ulcer
- Blister
- Erythema
- Ulcer
- Blister
Narrative
Description of Event or Problem
FOLLOWING A FIVE HOUR PRONE SPINAL SURGERY, THE PATIENT HAD REDNESS ON FOREHEAD AND CHIN. SUBSEQUENTLY BLISTERS DEVELOPED AND LEAKED SEROSANGUINOUS FLUID. A WOUND CONSULT WAS ORDERED, TRIPLE OINTMENT WAS APPLIED, AND VASELINE DRESSINGS WERE USED.
Description of Event or Problem
WE'VE BEEN USING THE 1937 HEADRESTS FOR YEARS NOW BUT LATELY WE'VE BEEN HAVING A LOT OF ISSUES WITH PRESSURE ULCERS ON THE FACE.
Additional Manufacturer Narrative
FREQUENT MONITORING AND REPOSITIONING WHEN REQUIRED AS DESCRIBED IN THE INSTRUCTIONS MAY HELP TO REDUCE THE OCCURRENCE OF SUCH INJURIES.
Description of Event or Problem
FOLLOWING A FIVE HOUR PRONE SPINAL SURGERY, THE PATIENT HAD REDNESS ON FOREHEAD AND CHIN. SUBSEQUENTLY BLISTERS DEVELOPED AND LEAKED SEROSANGUINOUS FLUID. A WOUND CONSULT WAS ORDERED, TRIPLE OINTMENT WAS APPLIED, AND VASELINE DRESSINGS WERE USED.