MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-10-23 for LIFETRACE SOFTRANS IUPC IUP 4000 31103826 manufactured by Graphic Controls Corp..
[111521]
A healthy infant was born with a 1cm lesion to the left temporal area of the scalp, but required no treatment to the wound. However, the hospital discharge of the newborn was delayed by two days for prophylactic iv antibiotic therapy to prevent infection. An experienced physician unsuccessfully inserted an iup 4000 in a pregnant woman during labor after meeting resistance during insertion. This iupc was discarded and a second iup 4000 was inserted successfully at a different position of the cervix. The physician stated that the end of the introducer may have been passed under the cervical edge by "about a 1/4 inch or so"
Patient Sequence No: 1, Text Type: D, B5
[7765690]
On 10/28/97 initial reporter from meridida hillcrest hosp reported that the facility did not file a medwatch report for this incident. This follow-up report is being submitted to correct the initial report in that regard.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243963-1997-00002 |
| MDR Report Key | 128721 |
| Report Source | 05,06 |
| Date Received | 1997-10-23 |
| Date of Report | 1997-09-23 |
| Date of Event | 1997-09-21 |
| Date Facility Aware | 1997-09-21 |
| Report Date | 1997-09-23 |
| Date Mfgr Received | 1997-09-23 |
| Date Added to Maude | 1997-10-30 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 |
| Generic Name | INTRAUTERINE PRESSURE CATHETER |
| Product Code | KXO |
| Date Received | 1997-10-23 |
| Model Number | IUP 4000 |
| Catalog Number | 31103826 |
| Lot Number | 050997 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 125920 |
| 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. Hospitalization; 2. Required No Informationntervention | 1997-10-23 |