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MAUDE MDR 1656763

MDR report key
1656763
Report number
1656763
Event key
0
Event type
3
Date of event
2009-12-11
Date received
2010-04-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1JP DRAINGBY*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-04-0901. R

Event Narratives#

D

Patient 1

EVENT DISCOVERED DURING RETROSPECTIVE CORE MEASURE REVIEW: PHYSICIAN/PA PROGRESS NOTE OF (B)(6) 2009 INCLUDES "JP: 10CC - REMOVED - HAD TO REOPEN LE INC SITE TO REMOVE JP DRAIN THAT BROKE. REMAINING DRAIN PIECE REMOVED INTACT. SKIN CLOSED WITH STAPLES."