MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-13 for TRANSMOTION MEDICAL, INC. TMM4-A manufactured by Transmotion Medical Inc..
[2999150]
(b)(6). Chair was in the back up/leg up/rails up position. She tried to exit at the foot end and the chair tipped. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[10298840]
This is a retroactive report based on the observations and our remedial action. Nothing was wrong with the device. It was simply incorrectly used by the end-user and/or patient. Warning labels were not adhered to.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2012-00006 |
| MDR Report Key | 2845006 |
| Report Source | 06 |
| Date Received | 2012-11-13 |
| Date of Report | 2012-11-07 |
| Date of Event | 2010-01-15 |
| Date Mfgr Received | 2010-01-15 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2012-12-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1441 WOLF CREEK TRAIL |
| Manufacturer City | SHARON CENTER OH 44274 |
| Manufacturer Country | US |
| Manufacturer Postal | 44274 |
| Manufacturer Phone | 3302394192 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSMOTION MEDICAL, INC. |
| Generic Name | TMM4 MULTIPURPOSE SURGICAL STRETCHER-CHA |
| Product Code | GBB |
| Date Received | 2012-11-13 |
| Model Number | TMM4-A |
| Catalog Number | TMM4-A |
| Lot Number | 2714-2718 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TRANSMOTION MEDICAL INC. |
| Manufacturer Address | 1441 WOLF CREEK TRAIL SHARON CENTER OH 44274 US 44274 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-13 |