Brand Name | RUMI II KOH-EFFICIENT |
Type of Device | KOH-EFFICIENT,RUMI,3.0CM |
Manufacturer (Section D) |
COOPERSURGICAL, INC. |
95 corporate drive |
trumbull CT 06611 |
|
Manufacturer (Section G) |
COOPERSURGICAL, INC. |
75 corporate drive |
trumbull |
CT 06611 |
|
Manufacturer Contact |
michael
marone
|
50 corporate drive |
trumbull, CT 06611
|
4752651582
|
|
MDR Report Key | 18717314 |
MDR Text Key | 335522085 |
Report Number | 1216677-2024-00004 |
Device Sequence Number | 1 |
Product Code |
HEW
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K954311 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign,Health Professional,User Facility,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/28/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 02/15/2024 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | KC-RUMI-30 |
Device Catalogue Number | KC-RUMI-30 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/22/2024 |
Was Device Evaluated by Manufacturer? |
Yes
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |
|
|