FDA.reportPublic FDA data

MAUDE MDR 125528

MDR report key
125528
Report number
125528
Event key
0
Event type
3
Date of event
1997-08-08
Date received
1997-08-23
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
1*FRACTURE KIT (LEG SPLINT)GRAHAM FIELD SURICALFZFHLM37159NIUNKNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11997-08-2301. O

Event Narratives#

D

Patient 1

BLOOD LEAKAGE AT SEAM LEVEL OF LEG SPLINT ALLOWING BLOOD TO PENETRATE BETWEEN THE TWO LAYERS OF VINYL. SEWN SEAM ALLOWS LEAKAGE. 8-18-97 AFTERNOON RUN FOR TRAUMA CASE. LEG SPLINT APPLIED TO A VERY BLOODY LEG. SPLINT WAS CLEANED PER PROTOCOL AND HUNG TO DRY. SEVERAL HRS LATER, ON A SECOND AMBULANCE RUN THE SPLINT WAS DRY AND FREE OF VISIBLE CONTAMINATE. THIS SPLINT WAS APPLIED TO PT OF 2ND RUN FOR AN INJURED LEG/ANKLE. NO BLEEDING FROM THIS PT. HOWEVER, UPON ARRIVAL AT THE HOSP, THERE WAS NOTED BLOOD ON THE PTS SHEET AND HIS PANT LEG WAS WET. HE DID HAVE NON WEEPING PIMPLY LIKE AREAS ON HIS LOWER LEG. THEREFORE, THE PT WAS TREATED FOR POSSIBLE BLOOD BORNE CONTAMINATION AND IS TO FOLLOW-UP WITH RETESTING AND HEPATITIS B VACCINATIONS.