FDA.reportPublic FDA data

MAUDE MDR 1905768

MDR report key
1905768
Report number
MW5018248
Event key
0
Event type
3
Date of event
2010-10-14
Date received
2010-11-16
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
1MATTRESS SHEETS (DISPOSABLE), 46' X 84"GLOBAL HEALTHCAREKME Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-11-1601. H; 2. R

Event Narratives#

D

Patient 1

PT CAME TO THE EMERGENCY ROOM. PLACED ON A CRIB WITH A DISPOSABLE FITTED SHEET. PT WAS LAYING ON HER RIGHT SIDE AND PRESENTS A 1ST DEGREE BURN. SKIN BIOPSY WAS REQUIRED. DATES OF USE: (B)(6), 2009. EVENT ABATED AFTER USE: YES.