BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE 92133

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE 92133 manufactured by Cochlear Bone Anchored Solutions Ab.

Event Text Entries

[186554374] This report is submitted on 31 march 2020.
Patient Sequence No: 1, Text Type: N, H10

[186554375] Per the clinic, the patient's underwent skin revision surgery during an abutment removal (date not reported). The implanted device remains.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6000034-2020-00874
• MDR Report Key: 9901548
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2020-03-30
• Date of Report: 2020-03-06
• Date Mfgr Received: 2020-03-06
• Date Added to Maude: 2020-03-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. KRISTEL KOHNE
• Manufacturer Street: 1 UNIVERSITY AVENUE
• Manufacturer City: MACQUARIE UNIVERSITY, NSW 2109
• Manufacturer Country: AS
• Manufacturer Postal: 2109
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BA210 ABUTMENT 8.5MM FOR FLANGE FIXTURE
• Generic Name: COCHLEAR BAHA CONNECT SYSTEM
• Product Code: LXB
• Date Received: 2020-03-30
• Model Number: 92133
• Catalog Number: 92133
• Lot Number: N/A
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COCHLEAR BONE ANCHORED SOLUTIONS AB
• Manufacturer Address: KONSTRUKTIONSV?GEN 14 PO BOX 82 M?LNLYCKE, 435 22 SW 435 22

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2020-03-30