| Brand Name | MEERA mobile operating table |
| Common Device Name | Table, Operating-Room, Ac-Powered |
| Manufacturer (Section D) |
| Maquet GmbH |
| kehler strasse 31 |
| rastatt |
| GM |
|
| Manufacturer (Section G) |
| Maquet GmbH |
| kehler strasse 31 |
|
| rastatt |
|
GM
|
|
| Manufacturer Contact |
|
diana
gutekunst
|
| kehler strasse 31 |
| rastatt
|
|
GM
|
|
| MDR Report Key | 50897657 |
| Report Number | 3013876692-2026-00109 |
| Device Sequence Number | 10711755 |
| Product Code |
FQO
|
| UDI-Device Identifier | 04046768124332 |
| UDI-Public | (01)04046768124332(11)240703 |
| Combination Product (Y/N) | N |
| Initial Reporter Country | BR |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Device Implanted Year | 2024 |
| Reporter Type |
Importer
|
| Report Source |
Foreign,User Facility,Company Representative |
| Initial Reporter Occupation |
Non-Healthcare Professional
|
| Type of Report
| Initial |
| Report Date (Section B) |
09/25/2026 |
| Report Date (Section F) |
09/25/2026 |
| 1 Device was Involved in the Event |
|
| 1 Patient was Involved in the Event |
|
| Is this an Adverse Event Report? |
Yes
|
| Is this a Product Problem Report? |
No
|
| Operator of Device |
Health Professional
|
| Device Model Number | 720001B0 |
| Was Device Available for Evaluation? |
Yes
|
| Is the Reporter a Health Professional? |
No
|
| Was the Report Sent to FDA? |
Yes
|
| Distributor Facility Aware Date | 09/18/2026 |
| Device Age | 2 YR |
| Date Report to Manufacturer | 09/25/2026 |
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | Not provided |
| Initial Report FDA Received Date | 09/25/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
Yes
|
| Date Device Manufactured | 07/03/2024 |
| Is the Device Labeled for Single Use? (Y/N) |
No
|
| Usage of Device |
Reuse
|
| Patient Sequence Number | 1 |
| Outcome Attributed to Adverse Event |
Hospitalization;
|
| Patient Sex | Unknown |
| Date Report Sent to FDA | 09/25/2026 |