AQUILEX FLUID CONTROL SYSTEM AQL-100S AQL-100CBS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for AQUILEX FLUID CONTROL SYSTEM AQL-100S AQL-100CBS manufactured by W.o.m. World Of Medicine Gmbh.

MAUDE Entry Details

Report Number3002914049-2019-00006
MDR Report Key8690337
Date Received2019-06-12
Date of Report2019-06-11
Date of Event2018-10-16
Date Mfgr Received2018-10-16
Device Manufacturer Date2018-05-04
Date Added to Maude2019-06-12
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 ContactDR. S MARKWORTH
Manufacturer StreetSALZUFER 8
Manufacturer CityBERLIN, 10587
Manufacturer CountryGM
Manufacturer Postal10587
Manufacturer G1W.O.M. WORLD OF MEDICINE GMBH
Manufacturer StreetALTE POSTSTRASSE 11
Manufacturer CityLUDWIGSSTADT, 96337
Manufacturer CountryGM
Manufacturer Postal Code96337
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameAQUILEX FLUID CONTROL SYSTEM AQL-100S
Generic NameHYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM
Product CodeHIG
Date Received2019-06-12
Returned To Mfg2018-10-29
Model NumberAQL-100CBS
Catalog NumberAQL-100CBS
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerW.O.M. WORLD OF MEDICINE GMBH
Manufacturer AddressSALZUFER 8 BERLIN, 10587 GM 10587


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-12

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