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MAUDE MDR 6072216

MDR report key
6072216
Report number
6072216
Event key
0
Event type
3
Date of event
2016-10-13
Date received
2016-11-02
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VENOSCOPE IITRANSILLUMINATORVENOSCOPEHJMVENOSCOPE III Y
2VENOSCOPE IITRANSILLUMINATORVENOSCOPEHJMVENOSCOPE III Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-11-0201. O

Event Narratives#

D

Patient 1

TRANSILLUMINATOR WAS USED TO IDENTIFY SUITABLE VEIN IN LEFT UPPER ARM FOR IV PLACEMENT FOR TPN INFUSION-DEVICE ON SKIN OFF/ON FOR 2 MINUTE PERIOD. AREA OF SKIN WAS NOTED TO BE WARM TO THE TOUCH AND HARD WHEN THE TRANSILLUMINATOR WAS REMOVED FROM THE ARM - LEFT ARM BLISTER AREA OF INJURY: 1.5 CM X 7 CM. MEPILEX DRESSING TO SITE; REMOVED ON (B)(6) 2016 AND LEFT OPEN TO AIR. SITE SCABBED OVER AS OF (B)(6) 2016. WE HAVE 2 DEVICES. DO NOT KNOW WHICH DEVICE WAS USED. DEVICE A AND DEVICE B. AGE OF DEVICE: DEVICE 1 - 6 YEARS; DEVICE 2 - 8 YEARS.