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..
[3043814]
(b)(6). Chair was in the back down/legs up/side rails up position. In the fetal position, he kept moving around and ultimately ended up so far down at the foot section to the point where it tipped. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[10298423]
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 it.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004082462-2012-00005 |
| MDR Report Key | 2844988 |
| 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 44274030 US 44274 0302 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-13 |