GYN PACK (GYCTF) 839 SMA73GYCT2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for GYN PACK (GYCTF) 839 SMA73GYCT2 manufactured by Cardinal Health 200, Llc.

Event Text Entries

[140736446] Ob gyn pack with incorrect number of raytec sponges. Contents form states should have 10 sponges and there were only 9.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5085489
MDR Report Key8473707
Date Received2019-04-01
Date of Report2019-03-26
Date of Event2019-03-07
Date Added to Maude2019-04-02
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 Report0

Device Details

Brand NameGYN PACK (GYCTF) 839
Generic NameGYNECOLOGICAL LAPAROSCOPIC KIT
Product CodeOHD
Date Received2019-04-01
Catalog NumberSMA73GYCT2
Lot Number978768
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCARDINAL HEALTH 200, LLC


Patients

Patient NumberTreatmentOutcomeDate
10 2019-04-01

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