MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-06 for UNK manufactured by Unk.
[17248383]
Unidentified male brought to er after mva. Required emergency thoracic surgery. A level #4 trauma pt. Protocol states that instrument count not required before closure due to severity of pt's condition. Upon inspection of instrument the tip was found missing from hemostat. On x-ray tip seen in chest cavity. Surgeons decided not to remove as it didn't appear to pose an immediated threat. Re-operation would have been more dangerous. Unable to identify instrument as it was discarded accidentally.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 74846 |
| MDR Report Key | 74846 |
| Date Received | 1997-03-06 |
| Date of Report | 1997-03-06 |
| Date of Event | 1997-01-29 |
| Date Facility Aware | 1997-01-29 |
| Report Date | 1997-03-06 |
| Date Reported to FDA | 1997-03-06 |
| Date Added to Maude | 1997-03-11 |
| 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 | BIOMEDICAL ENGINEER |
| 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 | UNK |
| Generic Name | HEMPSTAT |
| Product Code | HRQ |
| Date Received | 1997-03-06 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 74642 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-03-06 |