VAL011CTASA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-04 for VAL011CTASA manufactured by Medline Industries Inc..

Event Text Entries

[132200545] It was reported that during the post-operative evaluation of a patient, after an unidentified procedure, blue fibers were found in the patient's eye that the facility feels are coming from the back table cover. The facility reported that the event has occurred with eight patients. Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, procedural, or retrieval details to the manufacturer. No sample has been received for evaluation. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed. This is report six of eight.
Patient Sequence No: 1, Text Type: N, H10


[132200546] It was reported that during the post-operative evaluation of a patient, after an unidentified procedure, blue fibers were found in the patient's eye.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423395-2018-00070
MDR Report Key8218886
Date Received2019-01-04
Date of Report2019-01-04
Date of Event2018-12-01
Date Mfgr Received2018-12-13
Date Added to Maude2019-01-04
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 ContactKAREN TRUTSCH
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 60093
Manufacturer CountryUS
Manufacturer Postal60093
Manufacturer Phone8476434960
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Generic NameCATARACT PACK
Product CodeOJK
Date Received2019-01-04
Catalog NumberVAL011CTASA
Lot Number18IBM853
OperatorHEALTH PROFESSIONAL
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 2019-01-04

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