MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-04-19 for TEXAS MEDICAL INDUSTRIES manufactured by Tmi.
[2686821]
Pt was using trapeze ban to pull herself up in bed after surgery. The chain separated and broke free from system causing ban to come loose. Nurse caught bar, no pt harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5025152 |
| MDR Report Key | 2547846 |
| Date Received | 2012-04-19 |
| Date of Report | 2012-04-19 |
| Date of Event | 2012-04-09 |
| Date Added to Maude | 2012-04-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEXAS MEDICAL INDUSTRIES |
| Generic Name | TRAPEZE ASSEMBLY (BAR) |
| Product Code | ILZ |
| Date Received | 2012-04-19 |
| Model Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TMI |
| Manufacturer Address | 1409 INDUSTRIAL PARK ROYSE CITY TX 75189 US 75189 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-04-19 |