InjuryCCX
PILLOW, GENTLETOUCH, 7 INCH RT
Received May 3, 2023 · Event occurred Jun 1, 2022
Report 2921578-2023-00005 · MDR key 16865778
Device
Generic name
Patient Positioning Accessory
Manufacturer
Mizuho OsiModel number
1937Catalog number
1937
Lot number
APF220418
Product problems
- Use of Device Problem
- Use of Device Problem
Patient
Male
- Erythema
- Rash
- Blister
- Erythema
- Rash
- Blister
Narrative
Additional Manufacturer Narrative
THE GENTLETOUCH HEADREST PILLOW WAS NOT INFLATED ENOUGH AND WAS USED ON THE PATIENT FOR SURGICAL SUPPORT DESPITE THE WARNINGS MENTIONED IN THE INSTRUCTIONS FOR USE THAT SAY "DO NOT USE A PILLOW THAT HAS NOT FULLY EXPANDED". BASED ON THIS INFORMATION RECEIVED FROM THE INVESTIGATION, THE INCIDENT WAS DEEMED AS A USER ERROR WITH FAILURE TO FOLLOW INSTRUCTIONS.
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT GOT INJURED DUE TO THE USE OF PATIENT SUPPORT PILLOW DURING THE SURGERY.