Brand Name | BAHA 5 POWER SOUNDPROCESSOR, BROWN |
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 | 10073487 |
MDR Text Key | 191522963 |
Report Number | 6000034-2020-01385 |
Device Sequence Number | 1 |
Product Code |
LXB
|
UDI-Device Identifier | 09321502034616 |
UDI-Public | (01)09321502034616(10)COH1091560(11)161222 |
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Distributor
|
Type of Report
| Initial |
Report Date |
05/20/2020,04/27/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/19/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Expiration Date | 12/22/2016 |
Device Model Number | 95473 |
Device Catalogue Number | 95473 |
Device Lot Number | COH1091560 |
Was Device Available for Evaluation? |
No
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 05/20/2020 |
Distributor Facility Aware Date | 04/27/2020 |
Event Location |
Other
|
Date Report to Manufacturer | 05/20/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|