Brand Name | CENTURION CIRCLAMP |
Type of Device | CIRCUMCISION CLAMP |
Manufacturer (Section D) |
CENTURION MEDICAL PRODUCTS |
100 centurion way |
williamston MI 48895 |
|
Manufacturer (Section G) |
CENTURION MEDICAL PRODUCTS |
301 catrell dr |
|
howell MI 48843 |
|
Manufacturer Contact |
karen
kowalczyk
|
100 centurion way |
williamston, MI 48895
|
5175451122
|
|
MDR Report Key | 8890218 |
MDR Text Key | 154264928 |
Report Number | 1824619-2019-00003 |
Device Sequence Number | 1 |
Product Code |
HFX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative |
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
08/13/2019 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/17/2019
|
Initial Date FDA Received | 08/13/2019 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
Yes
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
|
|