MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1998-06-16 for BERKELEY VACURETTE F-TIP 6MM 21665 manufactured by .
| Report Number | 2124979-1998-00008 |
| MDR Report Key | 172925 |
| Report Source | 06 |
| Date Received | 1998-06-16 |
| Date of Event | 1998-05-12 |
| Date Mfgr Received | 1998-05-27 |
| Date Added to Maude | 1998-06-19 |
| 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 | BERKELEY VACURETTE F-TIP 6MM |
| Product Code | HHK |
| Date Received | 1998-06-16 |
| Model Number | NA |
| Catalog Number | 21665 |
| Lot Number | UNK |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 168141 |
| Baseline Brand Name | BERKELEY VACURETTE CANNULA, F-TIP |
| Baseline Generic Name | FLEXIBLE TIP CURETTE |
| Baseline Model No | NA |
| Baseline Catalog No | 21665 |
| Baseline ID | F-TIP VACURETTE |
| Baseline Device Family | F-TIP VACURETTE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-06-16 |