Brand Name | LITHOTOMY SURGICAL PACK |
Type of Device | GENERAL SURGERY TRAY |
Manufacturer (Section D) |
MEDLINE INDUSTRIES, INC. |
one medline place |
mundelein IL 60060 |
|
MDR Report Key | 15347117 |
MDR Text Key | 299154931 |
Report Number | 15347117 |
Device Sequence Number | 1 |
Product Code |
LRO
|
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 |
09/01/2022,11/10/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Model Number | DYNJP9010 |
Device Catalogue Number | DYNJP9010 |
Device Lot Number | 8582002072 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 09/01/2022 |
Date Report to Manufacturer | 09/02/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 09/02/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
|
|