MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB BAHA FLANGE & ABUTMENT; LXB: PRODUCT CODE

Catalog Number 93332

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Irritation (1941); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Manufacturer Narrative

This report is filed, march 8, 2016.The implanted device remains.

Event Description

Per the clinic, the patient experienced skin overgrowth, infection, inflammation and irritation at the implant site.Between the dates of (b)(6) 2012, the patient was treated with multiple courses of oral antibiotics, topical steroids and tissue reduction procedures (dates not reported) without resolution.Subsequently on (b)(6) 2012 the patient underwent a procedure to have the abutment exchanged.The implanted device remains.

• Brand Name: BAHA FLANGE & ABUTMENT
• Type of Device: LXB: PRODUCT CODE
• Manufacturer (Section D): COCHLEAR BONE ANCHORED SOLUTIONS AB; konstruktionsvagen 14; po box 82; moinlycke SE-43 5 22; SW SE-435 22
• Manufacturer Contact: nicole hille ; 13059 east peakview ave; centennial, CO 80111 ; 3037909010
• MDR Report Key: 5487780
• MDR Text Key: 39926778
• Report Number: 6000034-2016-00592
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Audiologist
• Type of Report: Initial
• Report Date: 02/18/2018

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: No Information
• Device Catalogue Number: 93332
• Device Lot Number: 126829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention