FDA.reportPublic FDA data

MAUDE MDR 8226845

MDR report key
8226845
Report number
1417592-2018-00150
Event key
0
Event type
3
Date of event
2018-02-08
Date received
2019-01-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KAREN TRUTSCH
Address
THREE LAKES DRIVE NORTHFIELD IL 60093 US
Phone
847-847-8476
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SET,BUCKET,ENEMAMEDLINE INDUSTRIES INC.FCEDYND70104HUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-0801. O

Event Narratives#

N

Patient 1

MANUFACTURER WAS NOTIFIED VIA MEDWATCH ((B)(4)) OF AN INCIDENT THAT OCCURRED AT AN END-USER FACILITY. IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING AN EXPLORATORY LAPAROTOMY ON (B)(6) 2018 DUE TO A BOWEL OBSTRUCTION WHEN TWO ENEMA CAPS WERE NOTICED INSIDE THE PATIENT. THE FACILITY REPORTED THAT THE PATIENT RECEIVED TWO ENEMAS ON (B)(6) 2018. ONE ENEMA WAS REPORTEDLY GIVEN BY A FACILITY NURSE AND ONE ENEMA GIVEN BY A STUDENT NURSE/INSTRUCTOR. THE FACILITY REPORTED THAT THE CAPS WERE NOT NOTICED AS MISSING DURING EITHER OF THE ENEMA ADMINISTRATIONS SO THE FACILITY IS UNSURE OF THE ACTUAL EVENT DATE THAT RESULTED IN THE ENEMA CAPS BEING LEFT INSIDE THE PATIENT. THERE WAS NO ADDITIONAL MEDICAL INTERVENTION REPORTED AND THE PATIENT IS REPORTEDLY DOING WELL. A SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION AND A ROOT CAUSE COULD NOT BE DETERMINED. DUE TO THE REPORTED INCIDENT, AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

IT WAS REPORTED THAT A PATIENT WAS UNDERGOING AN EXPLORATORY LAPAROTOMY DUE TO A BOWEL OBSTRUCTION WHEN TWO ENEMA CAPS WERE NOTICED INSIDE THE PATIENT FROM A PREVIOUS ENEMA AND REMOVED.