MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-15 for V. MUELLER * OS1059-010 manufactured by Carefusion.
[20412716]
During the intraoperative portion of a lumbar fusion procedure, the surgeon was using a mallet. When the mallet was handed back to the scrub nurse, a portion of the rubber end of the mallet was missing. One larger piece was found in the wound. The remaining tiny fragments were suctioned up with the neurosuction. The wound was once again checked by the surgeon. No remaining pieces were found. There was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2366666 |
| MDR Report Key | 2366666 |
| Date Received | 2011-11-15 |
| Date of Report | 2011-11-15 |
| Date of Event | 2011-11-07 |
| Report Date | 2011-11-15 |
| Date Reported to FDA | 2011-11-15 |
| Date Added to Maude | 2011-12-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V. MUELLER |
| Generic Name | MALLET |
| Product Code | HXL |
| Date Received | 2011-11-15 |
| Model Number | * |
| Catalog Number | OS1059-010 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN ROAD WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-15 |