MEDLINE INDUSTRIES, INC. DYNJHTLP01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for MEDLINE INDUSTRIES, INC. DYNJHTLP01 manufactured by Medline Industries, Inc..

Event Text Entries

[124670854] Incorrect number of xray 4x4 gauze included with surgical pack. Expected 10 but 11 were discovered during initial pre operative count.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7994482
MDR Report Key7994482
Date Received2018-10-23
Date of Report2018-10-05
Date of Event2018-10-05
Report Date2018-10-05
Date Reported to FDA2018-10-05
Date Reported to Mfgr2018-10-23
Date Added to Maude2018-10-23
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEDLINE INDUSTRIES, INC.
Generic NameLAPAROSCOPY KIT
Product CodeFDE
Date Received2018-10-23
Model NumberDYNJHTLP01
Catalog NumberDYNJHTLP01
Lot Number18CD0693
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-23

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