FDA.reportPublic FDA data

MAUDE MDR 8461375

MDR report key
8461375
Report number
2438477-2019-00014
Event key
0
Event type
3
Date of event
2019-01-25
Date received
2019-03-28
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
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DRIVERAISED TOILET SEATUNKNOWNILSRTL1200277RA* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-2801. H

Event Narratives#

D

Patient 1

(B)(4) IS THE INITIAL IMPORTER OR THE DEVICE WHICH IS A TOILET SEAT. PRODUCT HAS NOT BEEN RETURNED TO (B)(4) FOR EVALUATION. AFTER USE THE CONSUMER BRUSHED THE BACK OF HER RIGHT LEG AGAINST "A WING NUT:" IN THE CENTER FRONT OF THE SEAT. THE USER REPORTED THAT THE SHARP, UNEVEN SURFACE AND SIDE OF THE SCREW CUT INTO HER CALF CAUSING PROFUSE BLEEDING AND A VISIT TO THE EMERGENCY CENTER. THE PIECE OF TORN SKIN WAS REPORTEDLY SURGICALLY REMOVED, THE WOUND CLEANED AND BANDAGED AND A TETANUS BOOSTER ADMINISTERED. OUR TECH DEPARTMENT HAS ADVISED THAT THE DEVICE SHOULD HAVE A LOCKING MECHANISM IN THIS POSITION FOR SAFETY MADE COMPLETELY OF ROUNDED PLASTIC WITH NO SHARP EDGES, NO METAL SCREWS OR HARDWARE.