FDA.reportPublic FDA data

MAUDE MDR 21621

MDR report key
21621
Report number
MW1005795
Event key
0
Event type
3
Date received
1995-05-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ULTIMATE HOME COLONIC UNITENEMA BUCKETZYGON INTL., INC.FCE31291NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-05-020

Event Narratives#

D

Patient 1

RPTR STATES THE AD FOR THE PRODUCT HAS SO MUCH FALSE INFO IT IS ALMOST FUNNY. SHE IS VERY CONCERNED ABOUT THE HARM A PERSON COULD CAUSE HIMSELF WITH THE FALSE INFO AND THE UNIT. SHE CAN ONLY GUESS THAT THE DIRECTIONS FOR USE OF THE PRODUCT ARE DANGEROUS TO THE CONSUMER BASED ON THE COMMENTS MADE IN THE AD.