MDT2168286

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 2018-05-24 for MDT2168286 manufactured by Medline Industries Inc..

Event Text Entries

[109223748] It was reported that the blue operating room 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.
Patient Sequence No: 1, Text Type: N, H10


[109223749] It was reported that the blue operating room towels were "linting in chunks and may have caused an infection. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1417592-2018-00042
MDR Report Key7542472
Report SourceUSER FACILITY
Date Received2018-05-24
Date of Report2018-05-24
Date of Event2018-05-01
Date Mfgr Received2018-05-01
Date Added to Maude2018-05-24
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 ContactBERMON PUNZALAN
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 60093
Manufacturer CountryUS
Manufacturer Postal60093
Manufacturer Phone2249311514
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Generic NameTOWEL,OR,DSP,ST,BLUE,STD,6/PK,12PK/CS
Product CodeFRL
Date Received2018-05-24
Catalog NumberMDT2168286
Lot Number26017120008
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-05-24

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