| Brand Name | Namic |
| Common Device Name | PML,48,ADULT,FLL-MLL,PG |
| Manufacturer (Section D) |
| Medline Industries, LP - Namic |
| 10 glens falls technical pk. d |
| glens falls NY 12801 -386 |
|
| Manufacturer Contact |
|
lauren
glaeser
|
| three lakes drive |
| northfield, IL 60093--275
|
|
| MDR Report Key | 50038275 |
| Report Number | 3015910259-2026-00155 |
| Device Sequence Number | 18757223 |
| Product Code |
DRI
|
| UDI-Device Identifier | 10193489068337 |
| UDI-Public | 10193489068337 |
| Combination Product (Y/N) | N |
| Initial Reporter State | CA |
| Initial Reporter Country | US |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Company Representative |
| Initial Reporter Occupation |
Other Health Care Professional
|
| Type of Report
| Initial |
| Report Date (Section B) |
07/27/2026 |
| 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
|
| Operator of Device |
Health Professional
|
| Device Catalogue Number | 90701482 |
| Device Lot Number | 0000187418 |
| Was Device Available for Evaluation? |
Yes
|
| Is the Reporter a Health Professional? |
Yes
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 06/29/2026 |
| Initial Report FDA Received Date | 07/27/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
No
|
| Date Device Manufactured | 01/07/2026 |
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Usage of Device |
Unknown
|
| Patient Sequence Number | 1 |
| Patient Age | 55 YR |
| Patient Sex | Female |
|
|