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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH BONOS R WITH GENTAMICIN

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AAP BIOMATERIALS GMBH BONOS R WITH GENTAMICIN Back to Search Results
Model Number 01-0233
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Sudden Cardiac Death (2510)
Event Date 10/12/2017
Event Type  Death  
Event Description

Circulatory arrest, reanimation during surgery, primary successful in the intensive care, a renewed circulatory collapse, at the request of relatives no reanimation; patient died.

 
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Brand NameBONOS R WITH GENTAMICIN
Type of DeviceBONOS R WITH GENTAMICIN
Manufacturer (Section D)
AAP BIOMATERIALS GMBH
lagerstrasse 11-15
dieburg, 64807
GM 64807
Manufacturer (Section G)
AAP BIOMATERIALS GMBH
lagerstrasse 11-15
dieburg, 64807
GM 64807
Manufacturer Contact
volker stirnal
lagerstrasse 11-15
dieburg, 64807
GM   64807
MDR Report Key7057706
MDR Text Key92853594
Report Number9615014-2017-00028
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK123081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 11/24/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/24/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device EXPIRATION Date03/31/2020
Device MODEL Number01-0233
Device Catalogue Number01-0233
Device LOT Number17CA56131
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/21/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/24/2017 Patient Sequence Number: 1
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