FDA.reportPublic FDA data

MAUDE MDR 5145185

MDR report key
5145185
Report number
5145185
Event key
0
Event type
3
Date of event
2015-08-29
Date received
2015-09-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1JACKSON PRATTJP DRAINCARDINAL HEALTHGCDREF SU13-1309I Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-09-1001. H; 2. R

Event Narratives#

D

Patient 1

SURGEON REMOVED JACKSON PRATT AT BEDSIDE. THE JACKSON PRATT BROKE. THE JACKSON PRATT WAS UNABLE TO BE REMOVED IN ITS ENTIRETY AT THE BEDSIDE. THE END OF THE JACKSON PRATT WAS RETAINED. THE PHYSICIAN PERFORMED A DIAGNOSTIC LAPAROSCOPY AND JACKSON PRATT REMOVAL. THE END OF THE JACKSON PRATT DRAIN WAS FOUND TO BE IN PLACE AND WAS REMOVED COMPLETELY. THE FACILITY HAD TWO LOTS IN CIRCULATION. WE NARROWED THE BROKEN DEVICE DOWN TO ONE FO THESE TWO LOT NUMBERS 1150304 OR 1150306. DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE RETAINED PIECE IS NOT AVAILABLE.