Brand Name | MAJOR PACK-LF |
Type of Device | GENERAL SURGERY TRAY |
Manufacturer (Section D) |
MEDLINE INDUSTRIES, INC. |
one medline pl |
mundelein IL 60060 |
|
MDR Report Key | 13341994 |
MDR Text Key | 284363376 |
Report Number | 13341994 |
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 |
01/11/2022,11/02/2021 |
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 Catalogue Number | DYNJ04443L |
Device Lot Number | 21HMG119 |
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 | 01/11/2022 |
Date Report to Manufacturer | 01/25/2022 |
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 01/25/2022 |
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Patient Age | 32850 DA |
Patient Sex | Female |
|
|