GARRETT-OSSOFF-PILLING LARYN 25MM X 19CM 522196

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-13 for GARRETT-OSSOFF-PILLING LARYN 25MM X 19CM 522196 manufactured by Teleflex Medical.

Event Text Entries

[87304539] (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


[87304540] Metal shards were coming off the instrument. A metal shard did fall into the patient but the surgeon was able to retrieve the piece. No harm was done to the patient
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011137372-2017-00290
MDR Report Key6862624
Date Received2017-09-13
Date of Report2017-09-11
Date of Event2017-08-29
Date Mfgr Received2017-09-28
Date Added to Maude2017-09-13
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 G1TELEFLEX MEDICAL
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal Code27560
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameGARRETT-OSSOFF-PILLING LARYN 25MM X 19CM
Product CodeCAL
Date Received2017-09-13
Returned To Mfg2016-09-14
Catalog Number522196
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressRESEARCH TRIANGLE PARK NC


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-13

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