MAUDE MDR 1938525

MDR report key
1938525
Report number
MW5018686
Event key
0
Event type
3
Date of event
2010-11-24
Date received
2010-12-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
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
1MALE URINAL -GRADUATED URINAL WITH LID 32 OZ.MEDLINEFNPDYND802358215510025-0053 R
2MALE URINAL -GRADUATED URINAL WITH LID 32 OZMEDLINEFNP515610009-037 R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-12-2201. R

Event Narratives#

D

Patient 1

PT SUSTAINED CUT NEAR SCROTUM DUE TO VERY SHARP EDGES (BURS). NINE CASES RECEIVED (B)(6) 2010 RETURNED TO MEDLINE SECONDARY TO BURS.