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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONTRACT MANUFACTURER: AVALIGN GERMAN INSTRUMENTS HULKA-KENWICK UTERINE ELEVAT FCPS273MM UTERINE ELEVATOR

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CONTRACT MANUFACTURER: AVALIGN GERMAN INSTRUMENTS HULKA-KENWICK UTERINE ELEVAT FCPS273MM UTERINE ELEVATOR Back to Search Results
Model Number EO422R
Device Problem Patient Device Interaction Problem (4001)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/05/2018
Event Type  Malfunction  
Manufacturer Narrative

Investigation on-going. Additional information / investigation results will be provided in a supplemental report.

 
Event Description

During a gynecological procedure, a uterine elevator was clamped on the patient and fell off. There was no patient injury reported, no surgical delay. No additional intervention required.

 
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Brand NameHULKA-KENWICK UTERINE ELEVAT FCPS273MM
Type of DeviceUTERINE ELEVATOR
Manufacturer (Section D)
CONTRACT MANUFACTURER: AVALIGN GERMAN INSTRUMENTS
626 cooper court
shaumburg IL 60173
Manufacturer (Section G)
CONTRACT MANUFACTURER: AVALIGN GERMAN INSTRUMENTS
626 cooper court
schaumburg IL 60173
Manufacturer Contact
nicole broyles
615 lambert pointe drive
hazelwood, MO 63042
3145515988
MDR Report Key7916112
MDR Text Key122157844
Report Number2916714-2018-00023
Device Sequence Number1
Product Code HGC
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 09/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberEO422R
Device Catalogue NumberEO422R
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date09/05/2018
Event Location No Information
Date Manufacturer Received09/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 09/27/2018 Patient Sequence Number: 1
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