C-SECTION PACK HSAM00405

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-09 for C-SECTION PACK HSAM00405 manufactured by Avid Medical.

Event Text Entries

[69893988] A cesarean pack was opened and there was moisture found to be in the blood tube, and the towels and lap sponges were damp. Due to wetness/moisture present, the sterility of the pack was compromised. All packs from lot number were pulled and hospital supply company was notified. An avid medical complaint form was completed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5068407
MDR Report Key6399106
Date Received2017-03-09
Date of Report2017-03-09
Date of Event2017-02-14
Date Added to Maude2017-03-13
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 NameC-SECTION PACK
Generic NameOBSTETRICAL KIT
Product CodeOKV
Date Received2017-03-09
Returned To Mfg2017-02-17
Catalog NumberHSAM00405
Lot Number1218060
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerAVID MEDICAL


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-09

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