MAUDE MDR 7542894

MDR report key
7542894
Report number
1417592-2018-00043
Event key
0
Event type
3
Date of event
2018-05-01
Date received
2018-05-24
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
BERMON PUNZALAN
Address
THREE LAKES DRIVE NORTHFIELD IL 60093 US
Phone
224-224-2249
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TOWEL,OR,DSP,ST,WHITE,DLX,XR,4/PK,20PK/CMEDLINE INDUSTRIES INC.FRLMDT2168054XR84318010067R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-2401. O

Event Narratives#

N

Patient 1

IT WAS REPORTED THAT THE WHITE OR TOWELS "WERE LINTING IN CHUNKS AND LINTING MAY HAVE CAUSED AN INFECTION." NO INFORMATION WAS PROVIDED BY THE REPORTING FACILITY WHETHER THIS IS AN ACTUAL DIAGNOSIS AND WHAT TREATMENT WAS REQUIRED AS A RESULT OF THIS INCIDENT. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE REPORTING FACILITY WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

IT WAS REPORTED THAT THE WHITE OR TOWELS WERE "LINTING IN CHUNKS AND MAY HAVE CAUSED AN INFECTION."