MAUDE MDR 1309688

MDR report key
1309688
Report number
9612030-2009-00004
Event key
0
Event type
3
Date received
2009-02-05
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#

Contact
JILL SARAIVA
Address
15 HAMPSHIRE ST MANSFIELD MA 02048 US
Phone
508-508-5084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRAY WET SKIN SCRB/SM WING SPGWET SKIN SCRUB TRAYCOVIDIENGEC4158941589819986264* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-02-050

Event Narratives#

D

Patient 1

IT WAS REPORTED IN 2009 THAT A CUSTOMER HAD AN ISSUE WITH A WET SKIN SCRUB KIT. THE CUSTOMER STATED THAT THE SPONGE USED TO PREP THE INSIDE OF THE VAGINA IS COMING OFF OF THE STICK.

N

Patient 1

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.