MAUDE Adverse Event Report: COCHLEAR BONE ANCHORED SOLUTIONS AB UNKNOWN; COCHLEAR BAHA CONNECT SYSTEM

Model Number 93336

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Per the clinic, it was reported that the patient experienced chronic infections at the implant site.Treatment with oral and topical antibiotics were unsuccessful.Subsequently, the patient's abutment was removed under general anesthesia in (b)(6) 2019 (specific date not reported).The patient received iv antibiotics and steroids during the procedure.The infection has since healed.

• Brand Name: UNKNOWN
• 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: 10342085
• MDR Text Key: 201499313
• Report Number: 6000034-2020-01930
• Device Sequence Number: 1
• Product Code: LXB
• UDI-Device Identifier: 09321502022767
• UDI-Public: (01)09321502022767(10)174172(17)221107
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2020,07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2020
• Device Model Number: 93336
• Device Catalogue Number: 93336
• Device Lot Number: 174172
• 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: 07/30/2020
• Distributor Facility Aware Date: 07/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention