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MAUDE MDR 2561670

MDR report key
2561670
Report number
MW5025283
Event key
0
Event type
3
Date of event
2012-04-17
Date received
2012-04-30
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
109
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
1PRIMAPORE DRESSING 4" X 3&1/8"DRESSINGSKGX
2DRESSING CHANGE KIT W/CHLORHEXIDINEDRESSING CHANGE KITMCY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-04-3001. O

Event Narratives#

D

Patient 1

RASH UNDER DRESSING, CALL SUMMARY: PT CALLED TO REPORT SHE NOW HAS A RASH UNDER HER DRESSING. STATES IT HAS ITCHED FOR A WHILE, BUT NOW A RED RASH. NO SWELLING, DRAINAGE, ADVISED PT TO CLEANSE AREA WITH DRESSING KIT, ALLOWING EACH STEP TO DRY BEFORE MOVING TO NEXT STEP. THEN TO USE ONLY A STERILE 4X4 GAUZE DRESSING TAPED ON, FOR 2-3 DAYS. SHE AGREED. ADVISED SHE WILL NEED TO MONITOR THIS DRESSING AND CHANGE IT IMMEDIATELY IF GETS MOIST OR DAMP. SHE VOICED UNDERSTANDING. AGREED TO CALL BACK 24/7 IF RASH WORSENS, DOES NOT IMPROVE, ANY DRAINAGE, SWELLING, ETC. WILL REQUEST BRANCH STAFF FOLLOW UP. DID NOT SPECIFY WHICH DRESSING IS CAUSING THE ISSUE.