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

Model Number 93335

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Host-Tissue Reaction (1297)

Event Date 06/08/2020

Event Type  Injury  

Event Description

Per the clinic, the patient was placed under mac anesthesia on (b)(6) 2020, in order to excise excess skin at the implant site.

• Brand Name: BA400 ABUTMENT 10MM
• Type of Device: 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: 10228731
• MDR Text Key: 197571360
• Report Number: 6000034-2020-01668
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502022750
• UDI-Public: (01)09321502022750(10)182086(17)231212
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2020,06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/12/2023
• Device Model Number: 93335
• Device Catalogue Number: 93335
• Device Lot Number: 182086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2020
• Distributor Facility Aware Date: 06/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR