MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-11-13 for * 9228-00 manufactured by *.
[114505]
Head halter was saturated with duraprep solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037420-1998-00002 |
| MDR Report Key | 196811 |
| Report Source | 06 |
| Date Received | 1998-11-13 |
| Date of Event | 1998-10-13 |
| Date Mfgr Received | 1998-10-19 |
| Device Manufacturer Date | 1998-07-01 |
| Date Added to Maude | 1998-11-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | HSS |
| Date Received | 1998-11-13 |
| Model Number | 9228-00 |
| Catalog Number | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 186840 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| 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 | 1998-11-13 |