MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1997-12-31 for SG-100 9885864 REV C manufactured by .
| Report Number | 2242692-1997-00001 |
| MDR Report Key | 141069 |
| Report Source | 00 |
| Date Received | 1997-12-31 |
| Date of Event | 1997-11-03 |
| Date Mfgr Received | 1997-12-17 |
| Device Manufacturer Date | 1994-05-01 |
| Date Added to Maude | 1998-01-05 |
| 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 |
| Generic Name | SKULL POSITIONING DEVICE |
| Product Code | IWY |
| Date Received | 1997-12-31 |
| Model Number | SG-100 |
| Catalog Number | 9885864 REV C |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 132610 |
| Baseline Brand Name | MTD HEDREST |
| Baseline Generic Name | SKULL POSITIONER |
| Baseline Model No | SG-100 |
| Baseline Catalog No | 9885864 REVC |
| Baseline ID | * |
| Baseline Device Family | HEADHOLDER |
| 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 | 1997-12-31 |