MDT2168204

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-03-06 for MDT2168204 manufactured by Medline Industries.

Event Text Entries

[69105793] During a procedure, lint from a sterile or towel fell into the surgical site. The towel was being used as a drape around the surgical site. The surgeon noticed a piece of lint in the surgical site and removed it using forceps. The procedure continued without further incident. Sample was received but too small for testing. A root cause cannot be determined. Due to the reported incident and in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10


[69105794] It was reported lint from the or towel fell into incision.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2017-00011
MDR Report Key6379858
Report SourceUSER FACILITY
Date Received2017-03-06
Date of Report2017-03-06
Date of Event2017-02-13
Date Mfgr Received2017-02-15
Device Manufacturer Date2016-07-01
Date Added to Maude2017-03-06
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. MEGAN DEBUS
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 60093
Manufacturer CountryUS
Manufacturer Postal60093
Manufacturer Phone8477703962
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameOR TOWEL
Product CodeFRL
Date Received2017-03-06
Catalog NumberMDT2168204
Lot Number26016070008
OperatorPHYSICIAN
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-03-06

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