InjuryKIL

PRONE POSITIONER

Received Apr 5, 2001 · Event occurred Apr 4, 1997

Report 1643116-2001-00001 · MDR key 326013

Device

Generic name

Head Support For Prone Surgical Procedures

Manufacturer

Voss Medical Products

Model number

P-39-01

Catalog number

Lot number

UNK

Product problems

Use of Device Problem

Patient

UNKNOWN

Scarring
Pressure Sore/Ulcer

Narrative

Description of Event or Problem

PT REPORTED HAD A 5 TO 6 HOUR BACK SURGERY DURING WHICH THE PT WAS IN A PRONE POSITION. AFTER SURGERY, PT HAD A PRESSURE SORE ON CHIN THAT SCARRED ON HEALING. SCARRING WAS GOING TO REQUIRE SOME PLASTIC SURGERY TO REDUCE OR ELIMINATE. IT APPEARS PT HAD BEEN LEFT IN CONTACT WITH THE SUPPORT POSITIONER TOO LONG WITHOUT CONFIRMING AND OR REESTABLISHING BLOOD FLOW TO THE PRESSURE POINTS AS STATED IN THE PRODUCT INSTRUCTIONS.