MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-25 for GIANTURCO-HELFRICH-EBERBACK * manufactured by Cook Surgical.
[16147869]
Pt experiencing lower abdominal discomfort and was seen in emergency room on 11/30/1998. A piece of wire was removed which had become disconnected from hernia disk. At this time an x-ray revealed 2 to 3 more wires still attached to disk, to avoid further discomfort or possibly an internal bowel injury examining physician had pt scheduled for removal of associated wires. Two more wires removed on 12/08/1998.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 207848 |
| MDR Report Key | 207848 |
| Date Received | 1999-01-25 |
| Date of Report | 1999-01-04 |
| Date of Event | 1998-12-08 |
| Date Facility Aware | 1998-12-29 |
| Report Date | 1999-01-04 |
| Date Reported to Mfgr | 1999-01-04 |
| Date Added to Maude | 1999-01-29 |
| 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-HELFRICH-EBERBACK |
| Generic Name | HERNIA REPAIR SET |
| Product Code | EXN |
| Date Received | 1999-01-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | ORD# C-GHRS-10.0 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5.5 YR |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 201728 |
| 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-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 | 1999-01-25 |