FDA.reportPublic FDA data

MAUDE MDR 3893499

MDR report key
3893499
Report number
3893499
Event key
0
Event type
3
Date of event
2014-05-09
Date received
2014-06-11
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
1V. MUELLER HEMOSTATHEMOSTAT, SURGICALCAREFUSION 2200, INC.HRQUNKUNKNOWN* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-06-110

Event Narratives#

D

Patient 1

DURING OPEN HEART SURGERY, ONE SIDE OF A HEMOSTAT JAW WAS FOUND TO BE BROKEN OFF AFTER USE IN THE PROCEDURE. AFTER A THOROUGH FIELD AND FLOOR SEARCH WERE CONDUCTED WITHOUT SUCCESS, RADIOLOGY WAS CALLED TO PERFORM FLUOROSCOPY. THE FOREIGN BODY WAS LOCATED AND REMOVED FROM THE PATIENT'S THORACIC CAVITY.THERE IS NO INFORMATION FOR THE MANUFACTURER-ADDRESS, AGE, SERIAL NUMBER, MODEL NUMBER AND LOT NUMBER. THE DEVICE IS AVAILABLE AT NCH FOR EVALUATION. THE MANUFACTURER HAS NOT BEEN MADE AWARE.