TM6000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for TM6000 manufactured by The Or Company Llc.

Event Text Entries

[133352772] During use, the insufflation tubing occluded.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8256417
MDR Report Key8256417
Date Received2019-01-17
Date of Report2018-12-21
Date of Event2018-12-18
Report Date2018-12-21
Date Reported to FDA2018-12-21
Date Reported to Mfgr2019-01-17
Date Added to Maude2019-01-17
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
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 Report3

Device Details

Generic NameINSUFFLATOR TUBING SET
Product CodeNKC
Date Received2019-01-17
Catalog NumberTM6000
Lot Number1727955
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age1 DA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerTHE OR COMPANY LLC
Manufacturer Address1625 TACOMA WAY TACOMA WA 98409 US 98409


Patients

Patient NumberTreatmentOutcomeDate
10 2019-01-17

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