MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-10-02 for LIFETRACE SOFTRANS IUPC IUP 4000 31103826 manufactured by Graphic Controls Corp.
[83816]
The incident investigation indicated that the dr made two attempts to insert the iupc 4000 but had difficulty advancing it. So it was never actually used. An fse had been applied to the left parietal region of the fetal head. The hospitalization was not extended as a result of the scalp laceration and no antibiotics were given.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243963-1998-00001 |
| MDR Report Key | 190866 |
| Report Source | 05,06 |
| Date Received | 1998-10-02 |
| Date of Report | 1998-09-02 |
| Date of Event | 1998-08-18 |
| Date Mfgr Received | 1998-09-02 |
| Date Added to Maude | 1998-10-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFETRACE SOFTRANS IUPC |
| Product Code | KXO |
| Date Received | 1998-10-02 |
| Model Number | IUP 4000 |
| Catalog Number | 31103826 |
| Lot Number | 073198 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 179979 |
| Manufacturer | GRAPHIC CONTROLS CORP |
| Manufacturer Address | 1 CARNEGIE PLAZA CHERRY HILL NJ 08003 US |
| Baseline Brand Name | LIFETRACE SOFTRANS IUPC |
| Baseline Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Baseline Model No | IUP 4000 |
| Baseline Catalog No | 31103826 |
| Baseline ID | NA |
| Baseline Device Family | INTRAUTERINE PRESSURE CATHETER |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K950498 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-10-02 |