Brand Name | M/L-10 |
Type of Device | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
Manufacturer (Section D) |
MICROLINE SURGICAL, INC. |
50 dunham rd |
beverly MD 01915 |
|
MDR Report Key | 9865027 |
MDR Text Key | 184482094 |
Report Number | 9865027 |
Device Sequence Number | 1 |
Product Code |
GCJ
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial |
Report Date |
03/03/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 03/23/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Other
|
Device Model Number | 1002 |
Device Catalogue Number | 1002 |
Device Lot Number | 00126772 |
Was Device Available for Evaluation? |
Yes
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 03/03/2020 |
Event Location |
Hospital
|
Date Report to Manufacturer | 03/23/2020 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
Patient Age | 13870 DA |
|
|