FDA.reportPublic FDA data

MAUDE MDR 3961139

MDR report key
3961139
Report number
MW5037440
Event key
0
Event type
3
Date of event
2014-07-07
Date received
2014-07-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
306
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SURGIFISH VISCERA RETAINERVISCERA RETAINERGREER MEDICAL INCGCZUNKUNKUNK

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-07-2301. H; 2. L

Event Narratives#

D

Patient 1

MY HUSBAND (B)(6) HAD A SURGIFISH VISCERA RETAINER LEFT INSIDE HIS ABDOMEN FOR 12 DAYS BY MISTAKE DURING HIS FIRST SURGERY ON (B)(6), 2014, FOR AORTA BIFEMORAL BYPASS. HE HAD TO HAVE AN EMERGENCY OPERATION ON (B)(6), 2014 TO REMOVE THE SURGIFISH VISCERA RETAINER AND HE REMAINS IN CRITICAL CONDITION IN THE ICU AT (B)(6), AND TODAY IS (B)(6), 2014. (B)(6) HAS ALL THE RECORDS, CHARTS AND MEDICAL MISHAP REPORTS.