MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-03-18 for ALLEN MEDICAL SYSTEMS manufactured by Allen Medical Systems.
[1292435]
Patient was in a left lateral position for a procedure, with the left arm secured to the armboard. At some undetermined point in the procedure, the armboard became detached from the table. This was noted at the end of the procedure while the drapes were being removed. The armboard was still attached to the patient's arm by the soft safety strap. The safety strap caused the armboard to remain attached and pull the arm in a downward direction, hyper extending the elbow. No bruising noted, slight amount of redness noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015232 |
| MDR Report Key | 1638229 |
| Date Received | 2010-03-18 |
| Date of Report | 2010-03-18 |
| Date of Event | 2010-03-15 |
| Date Added to Maude | 2010-03-26 |
| 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 | ALLEN MEDICAL SYSTEMS |
| Generic Name | PATIENT POSITIONING ARM BOARD |
| Product Code | BTX |
| Date Received | 2010-03-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | ONE POST OFFICE SQUARE ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-18 |