MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 10MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93335
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Scarring (2061); Patient Problem/Medical Problem (2688)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient details unavailable at the time of this report, this report is submitted on (b)(6) 2018.(b)(4).
Event or Problem Description
Per the clinic, the patient experienced scarring and pain at the abutment site.Subsequently, the patient was treated with medication (type and date not reported).It was also reported the skin issue is persistent.
Additional Manufacturer Narrative
It was reported that the patient underwent cauterization of granulomas in the affected area at abutment site (date not reported).This report is submitted on 21 november 2019.
Additional Manufacturer Narrative
It was reported that the patient was placed under general anaesthesia to undergo skin revision surgery and an abutment change.The infection was treated with topical antibiotics.This report is submitted on 6 april 2020.

• Brand Name: BA400 ABUTMENT 10MM
• Common Device Name: COCHLEAR BAHA CONNECT SYSTEM
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvägen 14; po box 82; mölnlycke, 435 2 2; SW 435 22
• MDR Report Key: 7288132
• Report Number: 6000034-2018-00435
• Device Sequence Number: 2827891
• Product Code: MAH
• UDI-Device Identifier: 09321502021142
• UDI-Public: (01)09321502021142
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• PMA/510(K) Number: K110996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/11/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 93335
• Device Catalogue Number: 93335
• Device Lot Number: 3010110244428
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 10/25/2019; 03/11/2020
• Initial Report FDA Received Date: 02/22/2018
• Supplement Report FDA Received Date: 11/20/2019; 04/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention