LAP CHOLE PACK DYNJ0395986K

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-07 for LAP CHOLE PACK DYNJ0395986K manufactured by Medline Industries, Inc..

Event Text Entries

[101771488]
Patient Sequence No: 1, Text Type: N, H10


[101771489] A custom medline surgical pack was received with a note stating "the outer dust cover had a tear in it and there was also a tear on the blue drape cover-exactly in the same spot as the outer dust cover hole. " the holes had been circled by surgical staff, and were photographed. This was discovered prior to the start of a case, and no harm came to the patient. The field rep has been made aware and will pick up the pack to pass along to medline's quality team.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7319978
MDR Report Key7319978
Date Received2018-03-07
Date of Report2018-03-02
Date of Event2018-02-02
Report Date2018-03-02
Date Reported to FDA2018-03-02
Date Reported to Mfgr2018-03-02
Date Added to Maude2018-03-07
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLAP CHOLE PACK
Generic NameLAPAROSCOPY KIT
Product CodeFDE
Date Received2018-03-07
Model NumberDYNJ0395986K
Catalog NumberDYNJ0395986K
Lot Number17ID3137
Device AvailabilityY
Device Age0 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer Address3 LAKES DR NORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
10 2018-03-07

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