MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH BONEBRIDGE; EXTERNAL COMPONENT

Model Number SAMBA 2 MAGNET SYSTEM [AP407 MAGNET SYSTEM]

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pressure Sores (2326)

Event Date 07/13/2022

Event Type  Injury  

Manufacturer Narrative

Conclusion: according to the information received from the field the recipient experienced a skin necrosis in the post activation period likely due to a too strong external magnet.After treatment the magnet strength was decreased from #3 to #2 and the device stayed in use.This is a combined initial and final report.

Event Description

The device was activated in june 2022 with a strength #3 magnet and the user started to experience burning sensation after 8 days.Another 5 days later on (b)(6) 2022 there was necrosis of the skin and the ap was not used until this healed.Afterwards the magnet was switched to a strength #1 but it was too weak so a strength #2 was used.

• Brand Name: BONEBRIDGE
• Type of Device: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 18197991
• MDR Text Key: 328884876
• Report Number: 9710014-2023-001047
• Device Sequence Number: 1
• Product Code: MPV
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P990052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SAMBA 2 MAGNET SYSTEM [AP407 MAGNET SYSTEM]
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Female