CARDINAL HEALTH JACKSON-PRATT WOUND DRAINAGE SYSTEM SU130-1311

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for CARDINAL HEALTH JACKSON-PRATT WOUND DRAINAGE SYSTEM SU130-1311 manufactured by Cardinal Health 200, Llc.

Event Text Entries

[181791573] A (b)(6) year old patient underwent partial nephrectomy. Jp drain placed at that time. During bedside jp drain removal, drain fractured and a piece was retained. Patient required additional procedure to remove retained place. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093398
MDR Report Key9774647
Date Received2020-02-28
Date of Report2020-02-26
Date of Event2020-02-13
Date Added to Maude2020-03-02
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCARDINAL HEALTH JACKSON-PRATT WOUND DRAINAGE SYSTEM
Generic NameCATHETER, IRRIGATION
Product CodeGBX
Date Received2020-02-28
Catalog NumberSU130-1311
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-28

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