ETHICON POUCH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-08 for ETHICON POUCH manufactured by Ethicon/ Covidien.

Event Text Entries

[94550094] Endocatch pouch broken during a laparoscopic tissue retrieval.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073877
MDR Report Key7104461
Date Received2017-12-08
Date of Report2017-12-07
Date of Event2017-12-04
Date Added to Maude2017-12-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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 Sequence Number: 0

Brand NameETHICON
Generic NameENDOCATCH
Product CodeGCI
Date Received2017-12-08
Model NumberETHICON
Catalog NumberPOUCH
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerETHICON/ COVIDIEN
Manufacturer AddressIL 60805 US 60805

Device Sequence Number: 1

Brand NameETHICON
Generic NameENDOCATCH
Product CodeKDW
Date Received2017-12-08
Model NumberETHICON
Catalog NumberPOUCH
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerETHICON/ COVIDIEN
Manufacturer AddressIL 60805 US 60805


Patients

Patient NumberTreatmentOutcomeDate
10 2017-12-08

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