Brand Name | SAPPHIRE II PRO |
Type of Device | PTCA BALLOON |
Manufacturer (Section D) |
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. |
no.1st jinkui road |
futian free trade zone |
shenzhen guangdong, shenzhen guangdong CN 5 1803 |
CH CN 518038 |
|
Manufacturer (Section G) |
ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. |
no.1st jinkui road |
futian free trade zone |
shenzhen guangdong,, shenzhen guangdong, CN 5 1803 |
CH
CN 518038
|
|
Manufacturer Contact |
samantha
chan
|
no.1st jinkui road |
futian free trade zone |
shenzhen guangdong, shenzhen guangdong CN 5-1803
|
CH
CN 518038
|
|
MDR Report Key | 10045839 |
MDR Text Key | 208425202 |
Report Number | 3003775186-2020-01643 |
Device Sequence Number | 1 |
Product Code |
LOX
|
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K173680 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
distributor |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
05/12/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 05/11/2020 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Catalogue Number | 210-1035UU |
Device Lot Number | 4251161909 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 05/01/2020 |
Was Device Evaluated by Manufacturer? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|