MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BA400 ABUTMENT 6MM; COCHLEAR BAHA CONNECT SYSTEM

Model Number	93333
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is submitted on 6 august 2020.
Event or Problem Description
It was reported that the patient experienced recurrent skin infections at abutment site and subsequently underwent skin revision surgery to remove abutment.The patient was treated with oral antibiotics.

• Brand Name: BA400 ABUTMENT 6MM
• 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: 10371325
• Report Number: 6000034-2020-02041
• Device Sequence Number: 11624813
• Product Code: MAH
• UDI-Device Identifier: 09321502022736
• UDI-Public: (01)09321502022736(10)182121(17)240125
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K121317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/15/2020

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: 93333
• Device Catalogue Number: 93333
• Device Lot Number: 182121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2020
• Initial Report FDA Received Date: 08/05/2020
• 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