Brand Name | NIAGARA SI ULTRASONIC |
Type of Device | WASHER/DISINFECTOR |
Manufacturer (Section D) |
MEDISAFE UK LTD. |
unit 7 & 8, dunmow road |
bishops stortford |
hertfordshire, CM23 5GZ |
UK CM23 5GZ |
|
Manufacturer (Section G) |
MEDISAFE UK LTD. |
unit 7 & 8, dunmow road |
bishops stortford |
hertfordshire, CM23 5GZ |
UK
CM23 5GZ
|
|
Manufacturer Contact |
daniel
davy
|
5960 heisley road |
mentor, OH 44060
|
4403927453
|
|
MDR Report Key | 13826726 |
MDR Text Key | 297516094 |
Report Number | 9617134-2022-00001 |
Device Sequence Number | 1 |
Product Code |
MEC
|
Combination Product (y/n) | N |
Reporter Country Code | NO |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Distributor |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/18/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/04/2022 |
Initial Date FDA Received | 03/19/2022 |
Supplement Dates Manufacturer Received | 03/04/2022
|
Supplement Dates FDA Received | 07/29/2022
|
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |
|
|