MEDLINE LAP CHOLE PACK DYNJ49351

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-27 for MEDLINE LAP CHOLE PACK DYNJ49351 manufactured by Medline Industries, Inc..

Event Text Entries

[131904338] Medline lap chole pack #11 carbon steel blade extremely dull (could not cut skin). The defective blade was exchanged for a #11 stainless steel blade which functioned without issue.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5082672
MDR Report Key8203179
Date Received2018-12-27
Date of Report2018-12-27
Date of Event2018-12-24
Date Added to Maude2018-12-28
Event Key0
Report Source CodeVoluntary 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 Report0

Device Details

Brand NameMEDLINE LAP CHOLE PACK
Generic NameLAP CHOLE PACK
Product CodeFDE
Date Received2018-12-27
Model NumberDYNJ49351
Catalog NumberDYNJ49351
Lot Number18JBJ674
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES, INC.
Manufacturer AddressNORTHFIELD IL 60093 US 60093


Patients

Patient NumberTreatmentOutcomeDate
10 2018-12-27

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