MAUDE MDR 2992557

MDR report key
2992557
Report number
2992557
Event key
0
Event type
3
Date of event
2013-02-18
Date received
2013-02-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMERICAN ORTHOPAEDICSAWBSN MEDICAL, INCLGH0295-200** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-02-270

Event Narratives#

D

Patient 1

PHYSICAL THERAPIST (PT) WAS OPENING A WINDOW ON THE CAST ON THE RIGHT LEG ON THE ANTERIOR PORTION OF THE ANKLE. THE CAST SAW APPARENTLY WAS ALLOWED TO CONTACT THE SKIN WHICH RESULTED IN A SMALL RED AREA AND SMALL OPEN AREA. THE PHYSICIAN ASSISTANT WAS CONTACTED AND THE WOUNDS WERE TREATED AND A BANDAGE APPLIED. ON TUESDAY, A DIFFERENT DRESSING WAS ORDERED BY THE PHYSICIAN. ON WEDNESDAY, A 2ND CAST WAS APPLIED AND A WINDOW CREATED TO VIEW THE WOUND. THREE SMALL HORIZONTAL LINEAR RED AREAS WERE NOTED AND THE TOP ONE HAD A SMALL OPEN AREA. THE BOTTOM TWO AREAS ARE LIKELY THE RESULT OF THE STOCKING MATERIAL WRINKLING UNDER THE CAST, OR THE EDGE OF THE CAST AND THE TOP ONE AS A RESULT OF THE CAST COMING IN CONTACT WITH THE SKIN. THE AREA WAS CLEANED AND A TOPICAL ANTIBACTERIAL APPLIED AND MEPILEX DRESSING APPLIED PRIOR TO CASTING. ON THURSDAY MORNING, THE PHYSICIAN ASSESSED THE WOUND AND NOTED THAT THE PATIENT WAS COMPLAINING OF PRESSURE AND PAIN IN THE AREA ABOVE THE WOUND - LIKELY A RESULT OF THE CAST BEING TOO TIGHT. THE CAST WAS REMOVED BY THE PT. REHAB EDUCATOR TO DEVELOP COMPETENCY REVIEWS FOR SERIAL CASTING FOR OUR DEPT. SERIAL CASTING IS INFREQUENTLY PERFORMED.