FDA.reportPublic FDA data

MAUDE MDR 8404588

MDR report key
8404588
Report number
1417592-2019-00032
Event key
0
Event type
3
Date of event
2019-02-01
Date received
2019-03-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
BERMON PUNZALAN
Address
THREE LAKES DRIVE NORTHFIELD IL 60093 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TOWEL,OR,DSP,ST,BLUE,HEAVY,4/PK,20PK/CSMEDLINE INDUSTRIES INC.FRLMDT216830484318070121R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-03-0801. R

Event Narratives#

N

Patient 1

IT WAS REPORTED THAT THERE WERE MULTIPLE INCIDENTS WHERE BLUE OR TOWELS WERE NOTED LINTING DURING USE. THE LINTING FROM THE BLUE OR TOWELS REPORTEDLY REACHED THE SURGICAL SITE FOR AN UNIDENTIFIED NUMBER AND TYPE OF PROCEDURES. IRRIGATION AND CHANGING OF GLOVES WAS REPORTEDLY REQUIRED AFTER LINTING WAS NOTED. NO IMPACT TO THE PATIENT, THE PROCEDURE, OR THE TOTAL LENGTH OF THE PROCEDURE WAS REPORTED. DUE TO THE REPORTED INCIDENT AND REQUIRED MEDICAL INTERVENTION, THIS MEDWATCH IS BEING FILED. SAMPLES ARE NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE REOPENED AND REEVALUATED.

D

Patient 1

IT WAS REPORTED THAT LINTING FROM BLUE OR TOWELS REACHED THE SURGICAL SITE/S.