MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-10-16 for STAT MEDICAL 9223-00 NA manufactured by Stat Medical Division Of Deroyal Ind..
[20682492]
The pt was having a neuro procedure (left side of neck). As the procedure began smoke was seen coming out from under the left side of the drape. Drapes were removed and the pt's head halter was smoking/burning. Area was doused with saline solution. The head halter was removed revealing burn marks to the left side of the neck and ear. The procedure was later continued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 192284 |
| MDR Report Key | 192284 |
| Date Received | 1998-10-16 |
| Date of Report | 1998-10-13 |
| Date of Event | 1998-10-13 |
| Date Facility Aware | 1998-10-13 |
| Report Date | 1998-10-13 |
| Date Added to Maude | 1998-10-21 |
| 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 | STAT MEDICAL |
| Generic Name | HEAD HALTER |
| Product Code | HSS |
| Date Received | 1998-10-16 |
| Model Number | 9223-00 |
| Catalog Number | NA |
| Lot Number | 454793 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 186840 |
| Manufacturer | STAT MEDICAL DIVISION OF DEROYAL IND. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | STAT MEDICAL |
| Baseline Generic Name | HEAD HALTER |
| Baseline Model No | 9228-00 |
| Baseline Catalog No | 9228-00 |
| Baseline ID | NA |
| Baseline Device Family | TRACTION COMPONENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-10-16 |