GYNECOLOGICAL LAPAROSCOPIC KIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-23 for GYNECOLOGICAL LAPAROSCOPIC KIT manufactured by Cardinal Health 200, Llc.

Event Text Entries

[128200349] Sterile gynecological laparoscopy pack: suture bag adhesion end attached to back table had a dead bug between the adhesive and the bag end. Information sent to cardinal representative. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8099776
MDR Report Key8099776
Date Received2018-11-23
Date of Report2018-11-14
Date of Event2018-10-08
Report Date2018-11-14
Date Reported to FDA2018-11-14
Date Reported to Mfgr2018-11-23
Date Added to Maude2018-11-23
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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

Generic NameGYNECOLOGICAL LAPAROSCOPIC KIT
Product CodeOHD
Date Received2018-11-23
Returned To Mfg2018-10-12
Lot Number498746
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC
Manufacturer Address1320 DON HASKINS SUITE A EL PASO TX 79936 US 79936


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-23

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