EXTRACTION BAG FOR MIS 332800-000010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-19 for EXTRACTION BAG FOR MIS 332800-000010 manufactured by Teleflex Medical.

Event Text Entries

[78033594] (b)(4). The device has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[78033595] When the physician retracted the gall bladder and placed it into the bag, the memo bag burst leaving the specimen exposed. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006425876-2017-00200
MDR Report Key6649725
Date Received2017-06-19
Date of Report2017-06-05
Date of Event2017-06-05
Date Mfgr Received2017-07-20
Device Manufacturer Date2016-08-09
Date Added to Maude2017-06-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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
Manufacturer ContactJASMINE BROWN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9193614124
Manufacturer G1ARROW INTERNATIONAL CR, A.S.
Manufacturer StreetJAMSKA 2359/47
Manufacturer CityZDAR NAD SAZAVOU 591 01
Manufacturer CountryEZ
Manufacturer Postal Code591 01
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEXTRACTION BAG FOR MIS
Product CodeKGY
Date Received2017-06-19
Catalog Number332800-000010
Lot Number71F16G1285
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
10 2017-06-19

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