MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB SP MAGNET 3 BLACK; COCHLEAR BAHA ATTRACT SYSTEM

Model Number 95773

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Erythema (1840)

Event Type  Injury  

Manufacturer Narrative

This report is submitted on may 24, 2023.

Event Description

Per the clinic, the patient experienced skin erythema at the magnet site and subsequently was treated with topical antibiotics (specific date and duration not reported).The symptoms resolved, and the patient resumed use of the device.

• Brand Name: SP MAGNET 3 BLACK
• Type of Device: COCHLEAR BAHA ATTRACT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; mölnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: hemavathi muniesparan ; unit ug-1, vertical podium; no. 8 jalan kerinchi,; kuala lumpur, wilayah persekutuan 59200 ; MY 59200
• MDR Report Key: 16990055
• MDR Text Key: 315816047
• Report Number: 6000034-2023-01612
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502028691
• UDI-Public: (01)09321502028691(10)COH1414227(17)300409
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K131240
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 95773
• Device Catalogue Number: 95773
• Device Lot Number: COH1414227
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Male