MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-10 for ALLEN MEDICAL TRANSFER BOARD NOT AVAILABLE manufactured by Allen Medical Systems.
[1246661]
Pt was being moved from the operating room table to the bed and found that the allen medical transfer board had a piece of plastic sticking out and not secured. The piece of the transfer board was sharp, so the staff immediately turned to the pt to see if he was injured. They found a 4 inch bleeding wound on the back of the pt. The surgical team was made aware and the wound was addressed. The pt has since healed. After further analysis, the plastic end of the board broke after transfer of the pt. All transfer boards were removed from service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013477 |
| MDR Report Key | 1527188 |
| Date Received | 2009-11-10 |
| Date of Report | 2009-11-04 |
| Date of Event | 2009-10-20 |
| Date Added to Maude | 2009-11-19 |
| 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 TRANSFER BOARD |
| Generic Name | SURGIBORD |
| Product Code | FMR |
| Date Received | 2009-11-10 |
| Returned To Mfg | 2009-11-04 |
| Model Number | NOT AVAILABLE |
| Catalog Number | NOT AVAILABLE |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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. Required No Informationntervention | 2009-11-10 |