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

Model Number 01-0214

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Low Oxygen Saturation (2477); Sudden Cardiac Death (2510)

Event Date 06/06/2017

Event Type  Death  

Event Description

After cement application decreases of saturation in oxygen supply need for post-ventilation in intensive care, here by ct-diagnostic exclusion of pulmonary embolism (lae).

• Brand Name: BONOS R WITH GENTAMICIN
• Type of Device: BONOS 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 Key: 7057707
• MDR Text Key: 92853604
• Report Number: 9615014-2017-00027
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• 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 Received: 11/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 06/30/2018
• Device Model Number: 01-0214
• Device Catalogue Number: 01-0214
• Device Lot Number: 15FA56090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 91 YR
• Patient Weight: 47