| Brand Name | Transcend Stair Chair w/Trx |
| Common Device Name | Transcend Stair Chair w/Trx |
| Manufacturer (Section D) |
| FERNO |
| 70 weil way |
| wilmington OH 45177 |
|
| Manufacturer (Section G) |
| FERNO |
| 70 weil way |
|
| wilmington OH 45177 |
|
| Manufacturer Contact |
|
dawn
greene
|
| 70 weil way |
| wilmington, OH 45177
|
|
+1(937)283-2900
|
|
| MDR Report Key | 50168260 |
| Report Number | 1523574-2026-00083 |
| Device Sequence Number | 5252794 |
| Product Code |
FPP
|
| UDI-Device Identifier | 00190790004057 |
| UDI-Public | (01)00190790004057(11)260219 |
| Combination Product (Y/N) | N |
| Initial Reporter Country | CA |
| Number of Events Summarized | 1 |
| Summary Report (Y/N) | N |
| Reporter Type |
Manufacturer
|
| Report Source |
Company Representative |
| Type of Report
| Initial |
| Report Date (Section B) |
08/06/2026 |
| 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 | 0731402 |
| Device Catalogue Number | 0731402 |
| Device Lot Number | M252420 |
| Was Device Available for Evaluation? |
Yes
|
| Is the Reporter a Health Professional? |
No
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 07/08/2026 |
| Initial Report FDA Received Date | 08/06/2026 |
| Was Device Evaluated by Manufacturer? (Y/N) |
Yes
|
| Date Device Manufactured | 02/19/2026 |
| Is the Device Labeled for Single Use? (Y/N) |
No
|
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N) |
No
|
| Usage of Device |
Reuse
|
| Patient Sequence Number | 1 |
| Outcome Attributed to Adverse Event |
Other;
|
| Patient Sex | Unknown |