Brand Name | LEEP PRECISION GENERATOR |
Type of Device | LEEP PRECISION GENERATOR |
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
|
4752651665
|
|
MDR Report Key | 11665625 |
MDR Text Key | 250793561 |
Report Number | 1216677-2021-00073 |
Device Sequence Number | 1 |
Product Code |
HGI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K952483 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
10/31/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/14/2021 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
|
Device Model Number | LP-20-120 |
Device Catalogue Number | LP-20-120 |
Device Lot Number | N/A |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/30/2021 |
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 Treatment Data |
Date Received: 04/14/2021 Patient Sequence Number: 1 |
|
|