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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.O.M. WORLF OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM
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W.O.M. WORLF OF MEDICINE GMBH AQUILEX FLUID CONTROL SYSTEM; HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM Back to Search Results
Model Number AQL-100CBS
Device Problem Defective Device (2588)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/08/2019
Event Type  malfunction  
Event Description
We have been informed of the following event: "misc - scotty priddy # tel.(b)(6) contacted technical support on: (b)(6) 2019 regarding customer owned aquilex cart & scale serial (b)(4) the tm reported that cart & scale is having deficit issues.The tm would like this unit swapped out.Warranty expires on: 15-nov-2019 cart & scale is on case#: (b)(4) the pump is on case #: (b)(4).
 
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Brand Name
AQUILEX FLUID CONTROL SYSTEM
Type of Device
HYSTEROSCOPIC INSUFFLATOR, FLUID MONITORING SYSTEM
Manufacturer (Section D)
W.O.M. WORLF OF MEDICINE GMBH
salzufer 8
berlin, 10587
GM  10587
Manufacturer (Section G)
W.O.M. WORLD OF MEDICINE GMBH
alte poststrasse 11
ludwigsstadt, 96337
GM   96337
Manufacturer Contact
soeren markworth
salzufer 8
berlin, 10587
GM   10587
MDR Report Key8868256
MDR Text Key213698930
Report Number3002914049-2019-00008
Device Sequence Number1
Product Code HIG
UDI-Device Identifier04056702006556
UDI-Public04056702006556
Combination Product (y/n)N
PMA/PMN Number
K172040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAQL-100CBS
Device Catalogue NumberAQL-100CBS
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2019
Date Manufacturer Received07/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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