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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASCULEP RONGEUR, MANUAL

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ASCULEP RONGEUR, MANUAL Back to Search Results
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2019
Event Type  malfunction  
Event Description
The top part of the jaw broke off during surgery.
 
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Brand NameASCULEP
Type of DeviceRONGEUR, MANUAL
MDR Report Key9659241
MDR Text Key177377431
Report Number9659241
Device Sequence Number1
Product Code HAE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/24/2020
Event Location Hospital
Date Report to Manufacturer02/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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