MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-02-02 for GIANTURCO-HELFRICH EBERBACH HERNIA REPAIR SET C-GHRS-10.0 manufactured by .
| Report Number | 1820334-1999-00009 |
| MDR Report Key | 208263 |
| Report Source | 05,06 |
| Date Received | 1999-02-02 |
| Date of Event | 1998-12-08 |
| Date Mfgr Received | 1999-01-04 |
| Device Manufacturer Date | 1993-05-01 |
| Date Added to Maude | 1999-02-03 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GIANTURCO-HELFRICH EBERBACH HERNIA REPAIR SET |
| Generic Name | HERNIA REPAIR SET |
| Product Code | EXN |
| Date Received | 1999-02-02 |
| Model Number | NA |
| Catalog Number | C-GHRS-10.0 |
| Lot Number | 9264.177714.P79 |
| ID Number | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 201728 |
| Baseline Brand Name | GIANTURCO-HELFRICH EBERBACH HERNIA REPAIR SET |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | C-GHRS-10.0 |
| Baseline ID | NA |
| Baseline Device Family | SPECIAL SET |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K931936 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-02-02 |