Brand Name | LEEP PRECISION QUANTUM |
Type of Device | ELECTROCAUTERY, GYNECOLOGIC (AND ACCESSORIES) |
Manufacturer (Section D) |
|
MDR Report Key | 13019641 |
MDR Text Key | 282410049 |
Report Number | MW5106102 |
Device Sequence Number | 1 |
Product Code |
HGI
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Voluntary
|
Reporter Occupation |
Nurse
|
Type of Report
| Initial |
Report Date |
12/14/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/15/2021 |
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
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Patient Age | 60 YR |
Patient Sex | Female |
Patient Weight | 85 KG |
Patient Ethnicity | Non Hispanic |
|
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