MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-30 for GIANTURCO-HELFRISH-EBERBASH * manufactured by Cook Surgical.
[19146659]
The outer stainless wire of hernia mesh detached from the mesh and migrated to pt's left thigh. The stainless wire eventually poked through the pt's skin where the pt then pulled the remaining wire out through the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 179637 |
| MDR Report Key | 179637 |
| Date Received | 1998-07-30 |
| Date of Report | 1998-07-08 |
| Date of Event | 1998-06-16 |
| Date Facility Aware | 1998-06-16 |
| Report Date | 1998-07-06 |
| Date Reported to Mfgr | 1998-07-08 |
| Date Added to Maude | 1998-07-31 |
| 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 |
| 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 | GIANTURCO-HELFRISH-EBERBASH |
| Generic Name | HERNIA REPAIR SET |
| Product Code | EXN |
| Date Received | 1998-07-30 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | ORC# C-GHRS-7.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 YR |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 174673 |
| Manufacturer | COOK SURGICAL |
| Manufacturer Address | 925 SOUTH CURRY PIKE BLOOMINGTON IN 47402 US |
| Baseline Brand Name | GIANTURCO-HELFRICH EBERBACH HERNIA REPAIR SET |
| Baseline Generic Name | NA |
| Baseline Model No | NA |
| Baseline Catalog No | C-GHRS-7.0 |
| 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 | 1998-07-30 |